clinical research companies in europe

Top 17 Clinical Research Organizations (CRO) in 2023

In clinical research and treatment development, clinical research organizations (CROs) are frequently a sponsor’s most important partner and ally.

Depending on the nature of the clinical trial, and your existing capabilities as a sponsor to run the trial, the CRO company of your choice will typically be responsible for facilitating most of the micro and macro processes that go into designing and running a successful clinical trial.

When contracting a CRO to help you with your trial, you are transferring over a large portion of responsibility into the hands of your clinical research partner. The CRO of your choice will have the responsibility to control a variety of factors and processes of a clinical trial, and depending on their expertise, team structures, service offerings, internal resources and many other capabilities.

Your ability to find and contract a top CRO company that is the right fit for your unique trial will be a determinant of whether or not you will be able to operate a high-quality clinical trial that meets your expected timelines, budget and delivers a top-notch patient experience.

At ClaraHealth (a patient-centric recruitment acceleration platform) , we have put together an extensive list of the top CRO companies in the US and around the world.

This is not a cro rankings list, but rather a compiled list of some of the top clinical research organizations around the world. We have highlighted their strengths and core service offerings to make it easier for you to find the right fit clinical research partner.

In addition, we’ve put together a list of 9 fundamental questions to ask the prospective clinical research organization , which will help you to save time and ensure a right fit in picking the CRO.

Formerly known as Quintiles and IMS Health, IQVIA is one of the largest CROs in the world, with a large range of service offerings to help advance clinical research.

The company was founded in North Carolina in 1982, and has since grown to over 88,000 employees in more than 100 countries.

Some clinical trial solutions offered by IQVIA include:

• Assistance with protocol design
• Design of phase 1 clinical trials
• Assessment and improvement of phase 2 and 3 clinical trials
• Site identification & selection
• Patient recruitment
• Access to global laboratories via their wholly owned subsidiary Q2 Solutions

Parexel is a global clinical research organization that was founded in 1982, and specializes in conducting clinical studies on behalf of its pharmaceutical partners in order to accelerate and ensure the drug approval process of up-and-coming potential treatments. It currently operates in more than 50 countries, and is run by more than 18,000 employees around the world.

The company has a wide range of service offerings, covering nearly every type of clinical trial service to assist sponsors in running successful clinical studies.

Some clinical trial solutions offered by Parexel include:

• Clinical trial design and development for early phase, phase 2 & 3, and late phase clinical trials
• Clinical data management
• Decentralized clinical trials
• Clinical supply chain management
• Medical writing
• Regulatory affairs consulting
• Pharmacovigilance

3. PRA Health Sciences

PRA Health Sciences is one of the largest contract research organizations in the world. Founded in 1976 under the name “Anti-Inflammatory Drug Study Group”, the company was renamed to PRA in 1982. PRA Health Sciences employees more than 17,000 people, and provides coverage to more than 90 countries.

In 2021, PRA Health Sciences was acquired by the Ireland-headquartered global CRO leader ICON, which is also reviewed in this list.

Some clinical trial solutions offered by PRA Health Sciences include:

• Decentralized Clinical Trials Platform
• Protocol Consultation & Study Design
• Onsite Support services
• Customized Solutions for Biotech (such as asset valuation, regulatory strategy, engagement and support, drug development strategy and funding solutions)
• Clinical Diagnostics
• Site Commercial Solutions
• PRA’s Laboratories for Drug Development

Headquartered in Ireland, ICON was founded in 1990 in Dublin by co-founders John Climax and Ronan Lambre. The company has since grown to be one of the largest CROs in the world. As of September 2020, the company employs more than 15,000 people in 94 locations and across 40 countries.

ICON offers clinical research services which include consulting, clinical development and commercialization across a wide range of therapeutic areas.

In 2021, ICON acquired PRA Health Sciences, which is another CRO and global leader in clinical research services.

Some clinical trial solutions offered by ICON:

• Commercial Positioning
• Early Phase
• Functional Services Provision
• Laboratories
• Language Services
• Medical Imaging
• Real World Intelligence
• Site & Patient Solutions
• COVID-19 Clinical Operations

5. Syneos Health

Formerly known as InVentiv Health Incorporated and INC Research, Syneos Health is a publicly listed and global contract research organization. The company is based in Morrisville, North Carolina, and specializes in assisting companies with late-stage clinical trials. Syneos Health currently employs more than 25,000 people, and has offices across 91 locations.

In early 2018, INC Research was acquired inVentiv Health, and the merged company was named Syneos Health.

Some clinical trial solutions offered by Syneos Health include:

• Decentralized Clinical Trials Solutions
• Bioanalytical Solutions
• Phase II-III/Phase IIIb-IIIV
• Medical Device Diagnostics
• Clinical Data Management
• Clinical Project Management
• Clinical Monitoring
• Drug Safety & Pharmacovigilance
• Site and Patient Access

6. Labcorp Drug Development (Formerly Covance)

Formerly known as Covance and renamed to Labcorp Drug Development in early 2021, this CRO is one of the largest contract research organizations in the world. The company claims to provide the world’s largest central laboratory network, and has been rated as one of the best places to work for LGBTQ+ equality by the Human Rights Campaign organization in 2018 to 2021. Currently, Labcorp employs over 70,000 people and is able to support clinical research efforts in almost 100 countries around the world.

Some clinical trial solutions offered by Labcorp Drug Development include:

• Preclinical Services
• Clinical Trials
• Clinical Trial Laboratory Services
• Post-Marketing Solutions
• Medical Devices
• Data & Technology

Also known as Pharmaceutical Product Development, PPD is a large global contract research organization headquartered in Wilmington, North Carolina. Started as a one-person consulting firm in 1985, PPD has grown to over 27,000 employees worldwide, and provides a wide range of clinical research services to pharmaceutical and biotech companies.

Some clinical trial solutions offered by PPD include:

• Clinical Development
• Early Development
• Peri- and Post-Approval
• PPD Biotech
• PPD Laboratories
• Product Development and Consulting
• Site and Patient Centric Solutions

8. Fisher Clinical Services

Part of Thermo Fisher Scientific, Fisher Clinical Services is a global clinical research organization with headquarters in Center Valley, Philadelphia.

The company has been in the business of clinical supply chain management for over 20 years, and is focused exclusively on working with the packaging and distribution requirements of clinical trials across the globe.

Some clinical trial solutions offered by Fisher Clinical Services include:

• Biologistics Management
• Cell & Gene Therapy
• Clinical Ancillary Management
• Clinical Label Services
• Clinical Trial Packaging & Storage
• Clinical Supply Optimization Services
• Cold Chain Management & Expertise
• Direct-to-Patient
• Distribution & Logistics
• Strategic Comparator Sourcing
• Public Health Research

Established in 1997 under the name Kiecana Clinical Research, KCR is a full-service contract research organization that provides a variety of services for clinical monitoring, safety & pharmacovigilance, clinical project management, quality assurance and regulatory affairs.

KCR operates globally, and has offices in North America, Western Europe, Central Europe and Eartern Europe. The company currently employs more than 700 staff.

Some clinical trial solutions offered by KCR include:

• Trial Execution

10. Medpace

Founded in 1992 and based in Cincinnati, Ohio, Medpace is a midsize clinical contract research organization. The company has operations in over 45 countries, and employs over 2,800 people. Medpace provides support services for Phase I-IV clinical trials for pharmaceutical and biotechnology companies, which include central laboratory services and regulatory services.

Some clinical trial solutions offered by Medpace include:

• Biostatistics and Data Sciences
• Clinical Trial Management
• Drug Safety and Pharmacovigilance
• Medical Writing
• Quality Assurance
• Regulatory Affairs
• Risk-Based Monitoring
• Medpace Laboratories

11. Clintec

Now in business for over 22 years, Clintec is a medium-sized global contract research organization for pharmaceutical, biotech and medical device industries, with large expertise in oncology and rare diseases.

The company provides the flexibility and agility of a smaller-sized CRO, while also having a wide global coverage that large CRO companies are known for. Clintec is based in more than 50 countries, and was acquired by the leading global CRO IQVIA in late 2018.

Some clinical trial solutions offered by Clintec include:

• Project Management
• Data Management
• Biostatistics
• Global Feasibilities
• Patient Recruitment & Retention

12. Worldwide Clinical Trials

Bringing over 30 years of experience to the clinical research market, Worldwide Clinical Trials is a leading medium-sized global contract research organization. Founded by physicians with a dedication and commitment to advancing medical research, Worldwide Clinical Trials was the first customer-centric CRO.

Currently the company has coverage in more than 60 countries, and has extensive experience in a wide range of therapeutic areas, including central nervous system, metabolic, cardiovascular, oncology, rare diseases and general medicine.

Some clinical trial solutions offered by Worldwide Clinical Trials include:

• Bioanalytical Lab
• Early Phase Development
• Clinical Phase IIB-II Clinical Trials
• Phase IIIB-IV Clinical Trials
• Trial Management Technologies

Named #1 CRO in the world for operational excellence at the 2021 CRO Leadership Awards, CTI Clinical Trial And Consulting Services is a medium-sized global contract research organization that has been serving pharmaceutical companies since 1999.

Based in Covington, Kentucky, CTI has offices around the world in more than 60 countries, with coverage in North America, Europe, Latin America, Middle-East, Africa, and Asia-Pacific regions.

Some clinical trial solutions offered by CTI include:

• Feasibility
• Regulatory Affairs Study Start-Up
• Medical Monitoring
• Safety & Pharmacovigilance
• Clinical Services

14. Wuxi AppTec

Founded in 2000 as WuXi PharmaTech in the city of Wuxi, China, Wuxi AppTec has grown from a single laboratory into a leading global contract research organization with more than 28,000 employees, including 23,000 scientists and more than 30 research & development and manufacturing sites around the world.

With offices in Asia, U.S, Europe and the Middle East, the company is able to provide coverage to more than 30 countries around the world.

Some clinical trial solutions offered by Wuxi AppTec include:

• Small Molecule Drug R&D and Manufacturing
• Cell Therapy and Gene Therapy
• Drug R&D and Medical Device Testing
• Clinical Services (Phase I-IV)

15. Advanced Clinical

Founded in 1994 and based out of Deerfield, Illinois, Advanced Clinical is a midsize and full-service CRO that helps sponsors with running clinical trials. The company employs more than 700 staff, and offers a wide variety of services across many therapeutic areas. Advanced Clinical has global representation in over 50 countries around the world.

Some clinical trial solutions offered by Advanced Clinical include:

• eTMF & Document Management
• Global Medical Services
• Quality & Validation

16. Pharm-Olam

Pharm-Olam is a leading midsize CRO with global headquarters located in Houston, Texas and its European headquarters in Bracknell, United Kingdom. The company employs more than 800 staff, and has 25 offices around the world, with a global coverage in more than 60 countries.

The company has therapeutic expertise in 5 areas, including Rare & Orphan Disease, Infectious Disease & Vaccine, Oncology-Hematology, Allergy and Autoimmune.

Some clinical trial solutions offered by Pharm-Olam include:

• Study Feasibility
• Site Activation
• Patient Recruitment
• Medical Affairs
• Compliance & Training
• Clinical Monitoring & Operations

17. Clinipace

Founded in 2003 and based out of Morrisville, North Carolina, Clinipace is a global midsize full-service CRO with a focus on solution customization for clinical trials. The company has a large global coverage in more than 50 countries, and has offices in North America, South America, Europe and Asia-Pacific regions.

Clinipace’s therapeutic focus areas include Oncology, Nephrology and Urology, Rare Disease, Gastroenterology and Women’s Health. The company also has complete therapeutic expertise in Infectious Disease & Vaccines, Cardiology, CNS, Immunology, and Respiratory.

Some clinical trial solutions offered by Clinipace include:

• Clinical Analytics
• Clinical Technology and Ecosystem
• Functional Service Partnership (FSP)
• Regulatory & Strategic Product Development

9 Fundamental Questions To Ask A Top CRO Company Before Signing The Contract

1. which services does the cro provide.

CROs offload a lot of operational tasks from trial sponsors, which can touch any component of clinical trial operations. From formulating an overall study strategy and implementing technologies to support the operational processes of the trial, to picking and identifying sites, and supporting patients during the trial, the range of clinical services offered by a CRO tends to be vast and inclusive of all the typical services and support you will require for running a successful clinical trial.

However, not all CROs are the same in their service offerings, or are able to offer the same depth of capability within a seemingly same clinical trial support process. For this reason it is important to understand exactly which kind of clinical services and support you are looking to receive from the prospective CRO when running your clinical trial.

While services such as clinical monitoring and clinical trial management are offered by the majority of CROs, the specific needs of each trial are unique, and for this reason it is important to first identify what will be the unique services your trial requires. Completing this internal analysis first will help you to understand the extent to which a potential CRO partner will be able to provide all of these services.

Some CROs specialize in specific clinical trial functions which the company may label as a “core services”, in which case this is a sign the company will have more expertise, experience, and will be set up in a way to maximize their capabilities in providing support for these services compared to other services that the CRO offers.

For example, a CRO may include patient recruitment as part of its “core services”, which implies that they are highly skilled in and have the necessary infrastructure to design and implement a high-quality patient recruitment strategy.

Clara Health CRO Support Services: At Clara Health our specialty services include technology-augmented digital and patient advocacy recruitment, as well as patient support via our signature patient recruitment platform, which we use to upgrade clinical trials and deliver results sponsors look for in their recruitment and retention campaigns.

At Clara, we work alongside CROs to supplement and support clinical trials with modern and personalized capabilities that CROs do not typically have the bandwidth, corporate structure or infrastructure to support.

If you would like to learn more about exactly how our platform can upgrade your unique trial, feel free to book a Free 30 Minute Consultation Session Here with one of our in-house experts.

2. What Related Experience Does The CRO Have?

It is helpful to ask the prospective CRO company if they have any relevant experience in running clinical trials that would be an asset in designing and running your study. Previous experience in a related therapeutic area or in running a trial with a similar design allows CROs to have a deeper understanding into potential opportunities and challenges, increasing the likelihood of your clinical study being successful.

For example, if a sponsor is planning to run a trial in oncology, for the purpose of site identification and selection it would be valuable to partner with a CRO vendor that has expertise in this area, as they likely already have a good understanding of which sites will lead to optimal results.

However, it is also important to consider all factors when selecting a CRO vendor and not to rely on therapeutic experience as the sole qualifier for whether or not a potential CRO is a fit for your trial. While previous experience is beneficial, some sponsors close themselves off from working with vendors that have not worked in their therapeutic area, which significantly limits options when choosing a CRO partner that is truly a good fit for their clinical study.

This can impact the end result of your clinical study, as sponsors that are not successful in choosing a CRO vendor that is the right overall fit may face difficulties if the needs of their clinical study aren’t being properly met.

Clara Health: We have worked to provide support for clinical trials across a wide range of therapeutic areas and trial designs. Our specialty is filling in the gaps that CROs traditionally did not have to think about, which include digital patient recruitment, patient advocacy recruitment, and technology-augmented patient support.

Additionally, we are constantly building our proprietary data and running tests in a variety of therapeutic areas. These research efforts allow us to have a detailed understanding of the expected level of difficulty when recruiting particular patient populations, as well as allow us to predict with accuracy which segments of the targeted population will be likely to qualify in a particular study.

3. What Are The Communication Workflows & Expectations For Performing And Delivering Contracted Services?

It is important that you clarify what the expectations for communication will be between your prospective CRO vendor and your internal teams, as you will most likely be working with the CRO of your choice for the entire duration of your clinical trial.

There are a vast variety of factors and success determinants for a clinical trial, which are continuously undergoing change as the study unfolds. For this reason, it is recommended that you work with a CRO that is proactive in their communication, so that you are kept up to date with information about important changes as your clinical trial progresses.

A vendor that is proactive rather than reactive in their communication and approach to dealing with arising issues is one of the most important qualities in CRO. Challenging situations will naturally arise, and the promptness with which they are taken care of will significantly impact your clinical trial’s degree of success. Therefore, seeking a vendor that is able to match the standard of communication that you as a sponsor would like to experience throughout the duration of your partnership is one of the most critical steps in determining which CRO is the right fit for your clinical trial.

We’ve included a few additional questions pertaining to the communication structure and reporting expectations that you can ask a prospective CRO vendor to determine the degree of fit in this particular category:

Communication Expectations:

• If we were to move forward with you, which of your team members will be our main point of contact?
• How available will you be outside of the scheduled meetings to address any of our concerns or additional requests?
• What will be the frequency at which update meetings will be conducted, and who will be present at those meetings?
• Which clinical study processes will be reported on, and what will be the workflow for how we will receive this information?
• What will be the cadence at which we will receive progress reports?
• Would we be able to access metrics electronically via an interactive dashboard, or will you send us formal reports?

Clara Health: At Clara Health, we directly interact and actively work with several key stakeholders involved in running a clinical trial, which includes sponsors, CROs, sites, and patients. This unique position allows us to have a centralized perspective which helps us to see all the moving parts of a clinical trial at the same time, which helps to identify issues and relay this vital information and insight back to the sponsor (or other appropriate stakeholders) in the shortest time possible.

The ability to access this perspective allows us to gather the most accurate, complete, and up-to-date information about how the clinical trial is unfolding, and quickly becomes very valuable to sponsors for their clinical trial.

As an example, we may receive feedback from patients about having an unsatisfactory experience with a particular study site. We are able to aggregate and analyze this information, and relay our findings back to the sponsor and the study site to improve the experience for other patients.

4. What Is The CRO’s Client Satisfaction Record?

It is a good practice to request information or metrics from the prospective CRO vendor that can point to the degree of satisfaction of their past clients. Prior to signing the contract, vendors will naturally do their best to uplift their image and future value to you during their sales conversations with you and your team. It can be tricky to get an objective understanding of what the partnership experience will actually entail, especially when there are multiple vendors fighting for your commitment.

We recommend that you ask the prospective vendor to provide success metrics regarding areas of clinical trial operations that are going to be important for your trial.

For example, you may be interested in learning about the vendor’s relationship to finances, in which case it will be useful to ask them about situations in which they went over the planned budget, and investigate into the reasons behind that. Alternatively you may be concerned about potential delays in timelines, in which case it would be helpful to learn about metrics regarding the CRO’s ability to meet timeline expectations.

You may also request to talk to the prospective CRO’s past clients, which will help you to gain insight into what the relationship was like and give you the opportunity to examine if the way in which the particular CRO manages its relationships and performs its services meets the expectations that you would have for your potential relationship and for your clinical trial.

Clara Health: At Clara Health, our relationships with our partners and with our patients are most important to us. In the unique position where we fit in the clinical trial process, we have the opportunity to directly co-create the clinical trial patient experience with a variety of stakeholders, including sponsors, sites, CROs, and patients.

Our company’s values and culture have been directed and developed to be such that the client and patient experience is at the top of priority for all of our internal teams, and we work to provide the best quality of care to all stakeholders.

We have many testimonials from every type of partner we’ve worked with which we can happily share with you.

5. How Do You Adapt When Encountering Challenges With Running A Clinical Trial?

It is inevitable that challenges and unforeseen changes will arise throughout the operational clinical trial process, and for this reason it is important to work with a CRO vendor that can provide you with evidence of their flexibility and ability to adapt to sudden changes.

The ideal CRO partner is one that is highly consultative throughout the entire process, and has an ability and the initiative to deal with challenges at their seed stage, prior to them turning into major obstacles for the success of your trial.

CROs naturally have a large reach, and there are a lot of different clinical trial mechanisms and processes that are under their control. They are able to monitor and respond to what is going on in every key link in the chain of the clinical trial operation.

It is reasonable to expect this level of oversight from a CRO, and additional questions that can help you gain insight into this include:

• What are some examples where the CRO was effective at monitoring the health of clinical trials they’ve helped operate in the past?
• How quickly does the CRO respond to challenges or opportunities for improving the clinical trial experience?
• How well does the CRO gather & process information from study sites, study teams, patients & the sponsor, and what are their typical data analysis workflows?

It is also recommended to speak to the prospective CROs past clients to help you gain insight into how well they respond and adapt to the naturally arising challenges in clinical trials.

Clara Health: While CROs do have a large reach within the clinical trial, no CRO has complete visibility into every clinical process. They are not typically set up to support full visibility, which can manifest as a potential threat to your clinical trial as it unfolds. This is especially true for parts of the clinical trial processes that CROs naturally do not specialize and often subcontract, such as clinical trial recruitment.

At Clara, we are in a unique position in relation to other key partners involved in operating the clinical trial. We are in direct and frequent contact with patients, CROs, study sites, study teams, and the sponsor, and have a very deep understanding of the patient pipeline. This allows us the unique ability to go very deep into specific parts of the recruitment chain and investigate what is working and what is not working.

In addition, Clara functions as a resource for all partners in the clinical trial. For example, we work directly with site teams to ensure that they have access to a 3rd party that they can relay their needs to and receive fast support in case there is anything they require that can improve the patient recruitment process.

6. Which Parts Of Operating The Clinical Trial Will You Be Outsourcing?

Since there are so many processes and mechanisms that go into operating a clinical trial, CROs will always outsource some parts of running and managing the study. While you can expect that the prospective CRO will subcontract some of the work, it is important to find out which exact parts the clinical study will be outsourced.

There are certain basic and key clinical processes (such as site selection) that CROs almost always help with, and if you find that these parts of your trial are going to be subcontracted to another company, it is recommended to find out why the CROs operations are set up this way and how this would impact the service you will receive.

Ultimately what matters to you as a partner and client is that the quality of service and care that you will receive will be up to standard, and meet what was promised and what you are expecting. While this trust is important after you have signed the contract, it is recommended that prior to entering into such a significant commitment that you have evidence and the conviction that the CRO of your choice is truly the right fit and will deliver the quality of service that was being discussed.

Since it is impossible to predict exactly what the quality of this relationship and services performed will actually be like in practice, it is recommended that you understand the details of what will be done for your trial and how. Investigating how the CRO outsources and subcontracts services for a clinical trial will help you to gain necessary insight that you would need to make the correct vendor selection decision.

Clara Health: At Clara, we maximize the effectiveness of the digital component across the entire digital & recruitment spectrum, which is added on top of the existing capabilities of the CROs and other vendors involved in operating your clinical trial. In addition, we offer services that augment the CROs efforts, which has the potential to significantly improve the patient experience, operations flows, recruitment and retention performance, which is so important in ensuring the success of a clinical trial.

For example, if a CRO wants to have a great site relationship, we are able to come in as a third party on behalf of the sponsor and CRO and act as a resource and additional support for sites.

In another example, If a sponsor wants to have great relationships with the patient community, Clara is able to come in on behalf of the sponsor and develop these relationships while being perceived more neutrally by the patient community.

7. Do You Have Experience Running International Trials?

If you are planning on operating an international clinical trial, it is recommended to work with a CRO that has extensive experience in this area. While many CROs will offer near-global coverage, the level of experience with specific geographic locations can significantly vary from one vendor to another.

It is important to work with a CRO that has experience running clinical trials in the specific countries and regions you are planning to conduct your research in. Being compliant with the local rules and regulations for clinical testing is a very complex process that requires existing understanding and familiarity in order to ensure logistical smoothness and to mitigate legal risks. In operating a clinical trial, there are a multitude of clinical services and processes, which can greatly vary across the many regions in which you can conduct clinical testing.

A CRO that is lacking experience in operating international trials or operating in particular regions where you plan on conducting research may not be able to meet your desired quality and agility expectations, and therefore may not be the right fit for your international clinical trial.

Clara Health: In the past, we have provided international patient recruitment and digitally-augmented trial support services for clinical trials in the EU, Canada, UK, Australia and South America.

Clara Health is fully compliant to operate international studies everywhere in the world, with the exception of Russia and China.

8. What Is Your Relationship With Patients?

Patient-centric approach to designing and operating a clinical trial is becoming more and more crucial in the clinical research space. The ability of a sponsor and their CRO partner to understand the needs and characteristics of their target patient community is a significant determinant of whether or not the study will be a success.

A sponsor that has close and authentic relationships with the patient community tends to have a deeper understanding of how to create the best clinical trial experience that will attract patients and keep their interest throughout the clinical trial.

In addition, strong relationships with patients allow sponsors and CROs to forecast recruitment and patient retention pipeline with much higher accuracy. This ability is critical for ensuring the success of the trial and mitigating the risk of low enrollment. After an understanding of the patient population is acquired, sponsors gain the necessary insight to design a clinical trial that is not only favorable to their research results, but is also practical and will result in the enrollment numbers they are looking for.

While many CROs have already recognized the importance of patient-centricity and evolved the ways in which they design and operate clinical trials, other CROs have not yet made such a pivot in their values. It is important to understand the degree of importance the prospective CRO places on creating a favorable patient experience, and what kind of infrastructure the company has to support it.

At Clara, we recommend choosing a CRO partner that is adapting to the patient-centric model which is becoming more and more important for running a successful clinical trial.

Clara Health: Since early stages of our development, we’ve had a dedicated patient advocacy team that has been integral in shaping our company’s vision and operations. We have built our entire platform and recruitment infrastructure around creating the best experience for patients. Our teams, corporate values, service offerings and company infrastructure all work in the service of the patient.

In addition, over the many years of being in business we have heavily invested in building authentic patient community relationships that span across a variety of therapeutic areas. This has given us a unique ability to receive feedback directly from patients that is genuine and authentic around marketing materials, strategy for patient recruitment, and other services that we build for specific trials.

This ability to build partnerships with the patient community in an authentic way gives us a very unique ability to engage with the patient community on behalf of a pharmaceutical company, allowing our sponsor & CRO partners the opportunity to start conversations with patients through our in-house patient advocacy team.

If you would like to learn how Clara can help you to build a strong & authentic relationship with your target patient community, get in touch with us and we’d be happy to share our capabilities and previous results with you as they relate to your current or upcoming clinical trial.

9. How Is The CRO Going To Utilize Patient Input For Developing The Trial?

In the initial stages of clinical trial design, sponsors often determine the ideal patient profiles that would help them to drive the most favorable research outcomes for their study. While it is important for the success of your trial to determine who your ideal patients are, very often these projections do not match up with what is viable in practice.

At Clara, we often encounter study protocols that are not set up realistically for successful recruitment to be possible.

Common mistakes that are made when determining trial eligibility criteria and trial design include:

• Overestimating the interest in the clinical trial from the target patient population
• A lack of patient focus in the trial design
• A lack of convenience for patients in their participation
• Complicated and/or inefficient study experience flows
• Crafting the eligibility criteria around the patient population that is most likely to lead to favorable study outcomes, without conducting sufficient research to more accurately estimate the recruitment and retention difficulty of the group for a particular study

It is natural for there to be a “push & pull” between the research ideal and the real world practicality. It is important to determine the correct balance between these two sides for your trial, as going too far in either direction will decrease the chance of your clinical study’s success.

The nature of the industry as it is right now is such that there is excess research idealization and not enough emphasis on patient centricity. This distorted orientation has resulted in many clinical trials being unsuccessful, negatively impacting sponsors, patients and the entire clinical trials industry.

The ideal CRO partner should help you make sure that your protocol design sets your study up for success. The CRO should be able to help you determine the proper balance between the research ideal and the real world practicality, and back up their findings with sufficient research and patient data that can project your trial being a success.

Clara Health: When formulating a recruitment and retention plan for our clients, we begin with conducting thorough research into the target trial patient population. This allows us to get a clear understanding of which recruitment channels will yield the best results and what kind of marketing materials will resonate with the prospective study participants.

To ensure accuracy and real-world applicability of our research, we consult and collaborate with our internal patient advocacy and patient support teams, as well as with our clients and patients representing the target trial patient profiles. We then tie our findings back with any existing proprietary data that we have in connection with the therapeutic area or the prospective target patient group.

Our unique position within the clinical recruitment chain gives us the presence and deep-rooted access needed to effectively tap into any of the three patient traffic sources: digital recruitment, offline recruitment, or patient advocacy recruitment.

Once a recruitment campaign has gone live, we constantly monitor, analyze and optimize our performance to make sure that the processes we have in place are as efficient as possible and drive the greatest results. In addition, we have the capability to layer in any traditional advertising (such as billboard ads) if requested by the study sponsor.

• Success Stories

What do you do when your clinical study falls behind schedule?

We are a full-service clinical CRO with a relentless mission to complete your clinical trial on time. Backed by our strong operational strategy and leadership, a devoted team of medical professionals in each country and connections to prominent medical institutions, your clinical study will be in good, caring hands.

we simply outperform

Cardiovascular & Endocrinology

• Accell – 2.1 pts/site/month
• Rest of the World – 0.3 pts/site/month

Breast Cancer

• Accell – 0.9 pts/site/month
• Accell – 1 pts/site/month
• Rest of the World – 0.4 pts/site/month

Myelofibrosis

• Accell – 0.97 pts/site/month
• Rest of the World – 0.32 pts/site/month

Ulcerative Colitis

• Accell – 0.7 pts/site/month

Head & Neck Cancer

• Accell – 0.6 pts/site/month
• Rest of the World – 0.23 pts/site/month

ACCELL ONCOLOGY. DEVOTED TO FIGHTING THE DISEASE.

A subdivision of Accell Clinical Research, ACCELL ONCOLOGY is simply the only specialized oncology team in Russia and Eastern Europe. For over a decade we have been successful in delivering our promise to clients and patients. We are the dedicated CIS and Eastern European Union oncology people.

Our Services

From clinical research associates to hands-on founders, we fiercely pursue our strategic goal: deliver on schedule. We think of ourselves as your development partner, not a vendor.

Functional Outsourcing

Rescue studies, clinical trial management, strategic guidance and trial set-up.

Supporting clinical trials across border

Facilitating european clinical research.

ECRIN, the European Clinical Research Infrastructure Network,  facilitates multinational clinical research, through the provision of advice and services for the set-up and management of investigator or SME led clinical studies in Europe. ECRIN unites national networks of clinical trial units across Europe, through its scientific partners, to fulfil its vision of generating scientific evidence to optimise medical practice.

Supporting clinical research

Clinical operations

Support for the management of multinational clinical trials, from project conception through to operational management

Data centre certification

Ensures compliant, effective, and efficient data management services for European, non-commercial data centres

Infrastructure Development

Develop and strengthen our capacity, tools, and services for the benefit of the clinical research community

Share expertise with the clinical research community.

Access & cost of services

Learn more about how to access our clinical operation services.

We provide our 13 Member and Observer countries with diverse trial support services and contribute to infrastructure development projects with European and international partners.

ECRIN Tools

Adaptive Platform Trial Toolbox

The Adaptive Platform Trial Toolbox aims to collect the accumulated knowledge, experience, and resources (collectively termed as ‘tools’) from multiple projects and trials into a practical and guided toolbox to facilitate planning and conduct of future adaptive platform trials in any therapeutic area. 

Clinical Research Metadata Repository

The Clinical Research Metadata Repository is the free online tool to help scientific researchers find documents and data linked to a clinical research study, and to obtain information on the accessibility of those results.

Rare Diseases Clinical Trials Toolbox

The toolbox aims to collect the accumulated knowledge, experience, and resources generated by previous projects and/or research infrastructures and other organisations into a practical and guided toolbox to help understand the regulations and requirements for conducting trials, with special focus on investigator-initiated trials for rare diseases. 

Paediatric Tools

A series of tools and procedures to support the setup and management of multinational neonatal and paediatric clinical trials in Europe were developed through the PedCRIN project.

Risk Based Monitoring Toolbox

The Risk-Based Monitoring Toolbox provides information on tools available for risk assessment, monitoring and study conduct, the institutions where they are used, and other relevant details such as links and user feedback.

Regulatory and Ethical Tools (CAMPUS)

ECRIN CAMPUS is a central resource for information about clinical trial regulatory and ethical requirements covering 22 European countries and multiple study types such as clinical drug trials, clinical investigations of medical devices, combination drug-device studies and nutritional studies. 

ECRIN annual report 2023

R-LiNK Project Wrap-up: Enhancing Lithium Treatment for Bipolar Disorder

ICTD 2024: Data Centric Clinical Research

New ECRIN brochures available

CONSCIOUS II Autumn Course in Clinical Trials

Get business overview, business operations details specific to this market, products and services, latest developments and more...

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Select Companies

Europe Clinical Trials Companies

This report lists the top Europe Clinical Trials companies based on the 2023 & 2024 market share reports. Mordor Intelligence expert advisors conducted extensive research and identified these brands to be the leaders in the Europe Clinical Trials industry.

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Europe Clinical Trials Top Companies

Eli Lilly and Company

Pfizer Inc.

Novo Nordisk

*Disclaimer: Top companies sorted in no particular order

Europe Clinical Trials Market Concentration

Europe Clinical Trials Company List

Clinipace Worldwide

Thermo Fisher Scientific, Inc. (PPD)

F. Hoffmann-La Roche AG

Clinical Trials Market in Europe Report Snapshots

• Clinical Trials Market in Europe Market Size
• Clinical Trials Market in Europe Market Share
• Clinical Trials Market in Europe Market Trends
• Clinical Trials Market in Europe Companies

Clinical Trials Market in Europe Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

Europe Clinical Trials Market Get a free sample of this report

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ICON innovation

Our experience, knowledge and technological advancements converge to shape a better future for healthcare.

Applying AI to manage the risks and costs of postmarketing requirements

Translating intent to impact.

The triad of trust: Navigating real-world healthcare data integration

Ensuring the validity of clinical outcomes assessment data

Important considerations and best practices for effective COA implementation.

Advancements in Artificial Intelligence for site selection

Using human-enabled AI to enhance decision-making and minimise risk.

A multifaceted risk factor: Addressing obesity's impact across the disease spectrum

Considerations for clinical trial design focused on obesity treatments.

Optimising biotech funding whitepaper series

Navigating biotech's challenges and embracing a promising tomorrow.

Featured Solutions

Blended solutions

Bespoke, seamless solutions to meet unique sponsor challenges.

Digital Health Technologies

ICON acquires HumanFirst, a cloud-based technology company for life sciences supporting precision measurement in patient centred clinical research.

ICON provides full service outsourcing and flexible support for biotech specific needs such as due diligence and asset valuation.

Cardiac Safety Solutions

End-to-end cardiac safety solutions, including ECG, event monitoring, BPM, long-term Holter monitoring, ECHO and MUGA studies.

Early Clinical and Bioanalytical Solutions

Innovative early clinical solutions that will advance your drug development strategy.

Site & Patient Solutions

Transforming recruitment through patient-centric trials and real-world, real-time data.

Market Access

Expertise in mission-critical pricing, market access, and reimbursement. 

Specialty Laboratory Solutions

Supporting precision medicine programs across all phases of drug diagnostic co-development.

Ensuring patient recruitment success at a site level

9 July 2024. Register today.

Regulatory submission writing for NDA success

10 September 2024. Register today.

Mastering RMPs and RMMs: Tech-driven solutions for patient safety

12 September 2024. Register today.

ICON Insights

• 26 Jun 2024

Navigating shifting paradigms in dose optimisation and dose selection for oncology therapeutics

Innovations contributing to the reemergence of antibody drug conjugates

Navigating oncology development decisions for long-term success

Leveraging healthcare intelligence to increase diversity of oncology clinical trials

• 21 Jun 2024

Veeva R&D and Quality Summit 2024

• 14 Jun 2024

The rise and role of AI in medical imaging

• 06 Jun 2024

The next frontier: Digital health and patient safety

• 04 Jun 2024

ICON at SCDM 2024: Connecting the dots of clinical data management

Navigating regulatory landscapes: A guide to global submission standards

What’s happening in icon, how can we help.

• Cell and Gene Therapies
• Early Clinical
• Medical Device
• Rare & Orphan Diseases
• Real World Evidence
• Site & Patient Recruitment
• Strategic Solutions

• Medical Devices
• Advanced Therapy Medicinal Product
• Neurology / Psychiatry
• Cardiovascular
• Ophthalmology
• Gastroenterology
• Gynecology / Urology
• Endocrine / Metabolic Disorders
• Dermatology
• Rare Diseases

Representative Services

• Regulatory Affairs
• Medical Writing
• Project Management / Monitoring
• Patient Recruitment for Clinical Trials
• Quality Assurance
• CDISC Compliance
• Clinical Data Management
• Clinical Trial Biostatistics
• Medical Safety

Pharmacovigilance

• Memberships / Accreditations
• Corporate Development
• Locations / Contact

FLEXIBLE EXPERTS & RELIABLE SOLUTIONS

In clinical research, smallest details matter. Our commitment is to highest standards in quality, service and client confidentiality.

Minimizing Risks for maximum Benefits.

Keeping a watchful eye on the safety of your products, we collect and report your safety data. Because safety comes first.

Your Premium European Legal Representative.

Operating in all of the European Union and Switzerland, we are your link to successful business throughout Europe.

We are a full service contract research organization offering a complete range of clinical development and consulting services to pharmaceutical, biotechnology and medical device companies.

Nordic Life Science Days

FGK participates with Martin Krauss and Ursula Türcke at NLSDays, Malmö, Sweden.

32. BVMA Symposium, Munich

The 32nd BVMA Symposium will take place on November 22, 2024 at the Holiday Inn Munich - City Centre:

"Germany as a study location - new impulses for clinical research"

Register now:

Our experience spans multiple fields of medical indications.

Clinical studies with medical devices require a contract research organization that is familiar with the specific regulatory requirements.

▷FGK has broad experience in conducting clinical trials with all forms of biologics including cell therapy, ATMP and GMO.

As full service contract research organization, we have completed numerous clinical trials spanning a broad variety of indications in oncology.

CRO experienced in neurology − Our clinical research experts have extensive experience with novel therapeutic approaches

New challenges in dental clinical trials require profound support for study centers. ▷FGK can support sponsors with this

▷FGK has broad experience in cardiology and in vascular indications, including clinical research with e.g. stents, balloons and ablation systems.

▷FGK is a CRO with broad experience in infectious diseases research. Your clinical study can benefit from expert knowledge gained in various indications

▷FGK supports sponsors of clinical studies in ophthalmic indications. ✓ A contract research organization with experience in opthalmology

Clinical study support for pulmonology research. ▷FGK has an established network of investigational sites specialized in different methodologies

Based on many years of comprehensive experience in the design and conduct of clinical trials in various gastroenterological indications we can provide sound advice and service

▷FGK Clinical Research is experienced in conducting studies in classical indications of gynecology and urology.

Endocrine and metabolic diseases span a highly diversified range of conditions. ▷FGK has performed international Phase I studies up to post market studies

Clinical studies in dermatology use key imaging tools in evaluating efficacy endpoints. ▷FGK can advise on the best approach and support trial conduct

Clinical trials in rare diseases present challenges that need to be addressed early in the study design. ▷FGK knows how to overcome common obstacles

FGK Clinical Research GmbH

Heimeranstrasse 35 80339 Munich · Germany

T: +49 89 893 119 - 0 F: +49 89 893 119 - 20

info @ fgk-cro . com

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It’s time for a partner who drives you forward. Let’s devise strategies that position you to meet key milestones, faster.

Our brand update reflects the integrated and expansive approach we bring to your drug development journey.

Make speed, simplicity and scalability your competitive advantage. Our integrated CRO and CDMO solutions streamline your path to commercialization.

We’re honored to be recognized in the CRO Leadership Awards for the 13th consecutive year, a testament to our unwavering commitment to serving customers and patients.

Drive your drug development program forward. Partner with a leading provider of global clinical research solutions .

Unrivaled therapeutic expertise honed over decades

Deep expertise that covers more than 20 therapeutic areas, from established drug markets to cutting-edge R&D, to perform studies with exceptional quality.

Solutions tailored to accelerate your development

Dependable project management and delivery, underpinned by a global network, integrated data ecosystem and people-first approach.

Comprehensive laboratory services that transform drug development

Laboratory services built on innovation and award-winning technologies to enhance clinical trial performance and regulatory success.

Bring your life-saving therapies to the world

Transformative strategies that empower you to achieve key milestones faster. Because every moment counts in clinical research.

PPD FSP Solutions

The biotech mindset, optimized study planning, insights hub.

2nd Floor 53-55 Totleben Blvd. Sofia 1606, Bulgaria

Ulica grada Vukovara 284 Almeria Tower Zagreb 1000, Croatia

Czech Republic

Jachymova 26/2, 110 00, Prague 1, Czech Republic

Maison La Défense, 12 place de La Défense, 92974 Paris la Défense cedex France

5, Chavchavadze Avenue Tbilisi, Georgia

Tbilisi (Depot)

Unter den Linden 21 10117 Berlin, Germany

Bazis Office Center Kft., 1027 Budapest, Horvat u. 14-24, Hungary

Eurosky Tower Ufficio B/4 2˚Piano Via Giorgio Ribotta n.21 00144 Rome, Italy

Prosta Tower 13th floor ul. Prosta 32 00-838 Warsaw, Poland

B-dul Iuliu Maniu nr 7 Cladirea A, Intrarea 3, Etaj 1, Sector 6 Bucharest, 061072, Romania

3rd Floor Airport City, Omladinskih brigada 90b, Belgrade, 11070, Serbia

Levent Mahallesi Cömert Sokak No:1, Yapı Kredi Plaza C Blok Kat:17 No:40-41, Ofis DO-1, Beşiktaş/ İstanbul

1, Acad.Proskury str Kharkov, 61070 Ukraine

12 Kurenivsky lane, office B-101 Kyiv, Ukraine

Kyiv (Depot)

22, Sem'i Prahoyvykh str., Kyiv, Ukraine

United Kingdom

1st Floor Waterfront House Beeston Business Park Beeston, Nottingham NG9 1LA, UK

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• Company Insights
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• Phase 1 to 4 Clinical Trials
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Phase 1 to 4 Clinical Trial

Medical device clinical evaluation, software as a medical device clinical evaluation, bioequivalence clinical trials, biological clinical trials, herbal and nutraceutical clinical trials, in vitro diagnostics clinical evaluation, new drug and repurposed drug clinical trials, personalized medicine clinical trials, drug safety and pharmacovigilance services for us fda, drug safety and pharmacovigilance services for ema, drug safety and pharmacovigilance services for cdsco.

• CNS – Including Pain & Psychiatry
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• Cardiovascular
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• Endocrinology / Diabetology

Clinical Research Organization in US & India

Welcome to prorelix research cro, your drug development arm.

ProRelix Research is a Clinical Research Organization (CRO) with offices in the USA and India along with site networks in Australia, Thailand, Africa, and Europe supporting the clinical development of innovative new healthcare inventions and innovations to improve the health of patients. Every project is equally important to us. We first listen to you and strategize, aiming to a long-term partnership. We understand each project is unique on its own, and conscious clinical development, where efficiency is utmost and accuracy is supreme, is valuable and demanding to long-term success.

We provide services to help pharmaceutical, medical device, biopharmaceutical and nutraceutical/ herbal companies to transform scientific discoveries into new treatments. From clinical trial services, clinical data management services, pharmacovigilance services, medical writing services, drug regulatory affairs services, decentralized clinical trial services to leveraging real world insights, our therapeutic, technical, & operational ability is underpinned by a great conviction in what we do.

ProRelix Research has a global network of distinguished scientific leaders who are experts in a diverse range of therapeutic areas. We specialize in chronic diseases clinical trial services including oncology, respiratory, ophthalmology, endocrinology, immunology, dermatology, etc. Our reputation in clinical research services differentiates us from conventional clinical research organizations (CRO). We leverage our scientific leadership to establish and maintain the engagement of unique investigator networks for clinical research services.

Our Portfolio

Clinical trials play a pivotal role in the approval of new drugs as they most accurately reflect the effect of the drug in the human body. Since drug development is a costly and laborious process with the clinical trial phase...

Medical devices are an integral part of our lives from a simple thermometer to a life-saving pacemaker. Devising medical device clinical studies is complex and requires knowledge and experience-our experts at ProRelix Research can help you design studies depending upon...

The use of software to inform healthcare decisions is ubiquitous and is being utilized by patients, clinicians, and healthcare providers. Proper understanding, planning, and design of SaMD is essential for approval. ProRelix Research provides customized solutions and helps you adapt...

The success of a generic drug or biosimilar often hinges on the results of bioequivalence studies making it essential to partner with an experienced and reliable CRO to design and conduct bioequivalence studies. ProRelix Research offers full range service for...

ProRelix Research offers customized, end-to-end services for clinical trials of a broad range of biological products to help bring both innovator biologics and biosimilars to the market in a timely and cost-effective manner. We ensure compliance with regulatory requirements in...

The exponential growth in the natural product and dietary supplements field requires clinical trials to support safety and efficacy. ProRelix Research lends support at every step of your clinical trial journey to help you carve a niche in the dietary...

Diagnosis of diseases by clinicians using suitable tests guides treatment decisions and is necessary for improving and prolonging the health and well-being of patients. ProRelix Research partners with you to provide clinical trial support and ensure your device meets regulatory,...

ProRelix Research provides tailored end-to-end management of clinical trials keeping cost and patient safety at the forefront. We help you navigate the complex path of clinical trials by offering study support from patient recruitment to statistical interpretation to help you...

At ProRelix Research we understand that realization of the full potential of the emerging field of personalized medicine is dependent on the design and execution of clinical trials. We can help you circumvent the unique challenges associated with conducting precision...

ProRelix Research understands the utmost importance of protecting patient safety from clinical trials to real-world use of a new drug, biological or medical device. We help you develop appropriate pharmacovigilance plans and adverse event reporting systems in compliance with US...

Our experts at ProRelix research provide customized and comprehensive pharmacovigilance and safety monitoring programs in accordance with European Union (EU) regulations with an emphasis on patient well-being from research and development to post-market authorisation.

Patient safety and well-being lie at the heart of all our pharmacovigilance operations at ProRelix Research. We are with you every step of the way-from development of a pharmacovigilance system to regular reporting of safety and adverse events to regulatory...

How ProRelix Research can help you?

The successful execution and completion of a clinical trial are determined by several interconnected cross-functional expertise teams, including Medical Writing, Regulatory Affairs, Clinical Project Management, Clinical Data Management, Site Management, and Patient Recruitment,  Faster Ethics Committee Approval,  Pharmacovigilance, and much more.

A Quality driven Global Clinical Research Organization (CRO) that can truly understand your needs and help you to achieve your goals by minimizing the complexity across functional teams.  We at ProRelix Research strive to bring forth the best clinical research services managed by therapeutically sound experts and professionals who are having over a decade of international regulatory experience in conducting complex clinical trials into simple ones.

Also, our extensive knowledge, quality work, and global recognition make us an ideal choice for the rising demand for conducting holistic clinical trials which include New/ Repurposed  Pharmaceutical Products, Biological, Herbal, Nutraceutical, In Vitro Diagnostic Devices, Therapeutic Medical Devices, and more.

We are dedicated to follow the best ethical and clinical practices when conducting clinical studies while keeping the safety of all of our participant at core. Our motto is to provide our clients with prompt clinical study management, reliable clinical data with integrity, and ethical conduction of the clinical trials. The uniqueness of our services and functionality is that we not only design the ideal mechanism for better functionality of your trials but we also provide you a lending hand in all those processes and take you through them from the start till the end to reach your goal.

Our service portfolio includes Clinical Trial Project management, Phase 1 to 4 Clinical Trials, Drug Regulatory Affairs, Medical Writing, Clinical Data Management, Pharmacovigilance, Clinical Operations, etc . We are open to clients from all over the world and have a strong presence in USA and India and strategic partners in Europe, Australia. Let’s commit ourselves to better healthcare systems all around the world by ethical, prompt, and reliable clinical research studies!

Our  Highlights

• Clinical Research Organization with Global Services Capability in USA, India, Europe, and Australia
• Phase 1, 2, 3, and 4 clinical trial services for (i) Pharmaceutical (ii) Medical Device (iii) Herbal/ Neutraceutical
• Organized Structure and Reputation
• Experienced and  Best Service Portfolio
• Adaptability and Flexibility with Sponsor/Study Requirements
• Quality Assurance and Transparency

CRO Services

Clinical research services.

Our clinical research service focuses on the Quality, Ethics, and Well-being of the clinical trial subject… Read More

Data Management & Statistics Services

At ProRelix Research we are a team of experienced people who are well aware… Read More

Medical Writing Services

ProRelix Research’s medical writing service capabilities range from Clinical Research, Regulatory… Read More

Regulatory Affairs Services

ProRelix Research’s Regulatory Affairs services provide expert support in drug development programs. Read More

Recent Posts

Why is india becoming a hot destination for global clinical trials.

With a population of approximately 1.4 billion people, healthcare expenditure of 2.6% of the country’s gross domestic product (GDP), and the presence of several multinational pharmaceutical and biopharmaceutical companies in […]

Requirements to Conduct First-in-Human (FIH) Clinical Trials for Biopharmaceuticals

The transition of a drug, medical device, or biopharmaceutical from the laboratory bench to bedside involves a long series of steps starting from drug discovery, computational chemistry, in vitro and […]

The Promise of Clinical Trials in Advancing Solid Tumour Cancer Treatments

According to the National Cancer Institute (NCI), a solid tumour is a mass of tissue that usually does not contain cysts or liquid areas such as sarcomas (arising from connective […]

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I would highly recommend Prorelix Research as a client‐focused company with a strong patient database that delivers on its promise to deal with patient recruitment.

Global Pharma Company

We selected the Prorelix Research because of its comprehensive nature, flexibility and reliability. We were happy as ProRelix Research proved to be a best solution to our clinical trial operations .

Indian Pharma Company

We are very happy to have found Prorelix Research, during our relationship, ProRelix Research has delivered best services for our medical device study project..

Global Medical Device Company

The quality of the service provided by ProRelix Research matches the sophistication of their services platform. Their services have helped us thoroughly and promptly.

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Velocity Expands to 17 Sites in Europe

Velocity Clinical Research, the leading multi-specialty clinical sites organization, today announces its further expansion in Europe, adding five sites in Poland after acquiring multi-site network KO-MED Centra Kliniczne and two in Germany, having acquired The Pulmonary Research Institute at the LungenClinic Grosshansdorf and KLB Gesundheitsforschung Lübeck.

Velocity’s growth is accelerating across Europe, with 17 locations in the U.K., Poland, and Germany. The company is now one of the largest site organizations in Europe in addition to it being the largest sites business in the United States.

Dominic Clavell, European General Manager for Velocity, said, “Our European network is now larger than the size of Velocity’s network when it was sold to GHO Capital. Velocity is building an integrated network of sites that can change the paradigm and we have the size and scale where we can recruit enough patients, either for entire studies or contribute significantly to country targets in Europe. This dramatically speeds up site start-up times, saving considerable time for CROs and Sponsors.”

The acquisition of KO-MED is Velocity’s first foray into Oncology research, which accounts for roughly 40-50% of clinical trials globally. KO-MED has been the leading multi-site network in Poland since 2020, having enrolled over 9,000 patients into clinical research.

Marek Konieczny, MD PhD, President of KO-MED’s Board, said, “I have been involved in clinical research for over 25 years and there are always new challenges which stimulate me to find new approaches. In most cases, the participant of a clinical trial benefits from taking part, which is of great importance, especially in oncological trials. I’ve seen first hand when under my supervision, patients who previously had very little chance of surviving now live longer, enjoying more time with loved ones.”

“Being a part of Velocity is a wonderful opportunity to merge capacities with the best clinical trials network in the world. Integration rather than affiliations allows us to unite with common values. In my new role as Vice President Corporate Development (CEE) and Medical Director (CEE) together with my expertise of building out a site network, I intend to support the development of Velocity in Poland and in Europe more widely.”

The Pulmonary Research Institute has carried out over 300 studies since opening 25 years ago, leading research in bronchial asthma, bronchiectasis and pulmonary fibrosis. Anne-Marie Kirsten, MD, PhD, and Henrik Watz, MD, PhD, both join Velocity as principal investigators, being leaders in Pulmonary research in Europe.

Dr. Kirsten said, “Since the beginning of our career as internal medicine doctors and pneumologists, we realized that only clinical research holds the potential for innovation. The therapeutic progress over the last 15 years in COPD, pulmonary fibrosis and asthma is a major achievement towards an improved quality of life of our patients, which we substantially contributed to.”

Dr. Watz added, “With the backbone of Velocity we clearly see the unique opportunity for faster recruitment, use of common resources and infrastructure and the collaboration within a family of experienced and highly professional set of researchers. As doctors, we will be able to focus more on our patients and their needs because administrative tasks will be handled by the common infrastructure backbone Velocity provides.”

KLB Gesundheitsforschung Lübeck is located in the heart of the city of Lübeck, conducting clinical studies for respiratory diseases since 2008.

Andrea Ludwig-Sengpiel, MD, PhD, managing partner of KLB, commented, “We are undergoing a structural change in our working world. Digitalization, changing demands on employees and their redefined needs are important issues that can be better addressed through integration into a large network. Velocity brings together very experienced and highly professional study sites with comparable standards of quality and scientific work, creating many synergies from which all participants can benefit. This is what makes integration into this network so attractive. We are pleased to be part of an international company.”

The new sites join Velocity’s existing four sites in Germany, one in Poland and five in the U.K., of which three are newly-opened greenfield sites. Velocity has almost 100 locations globally and access to more than 220 principal investigators and one million patients.

Velocity’s sites are fully integrated via a centralized infrastructure and common technology backbone, allowing for superior patient enrolment and consistent, high-quality data delivery. As a result, CROs and biopharma companies can benefit from faster and simplified access to patients in North America and Europe.

About Velocity Clinical Research

Velocity is the leading integrated site organization for clinical trials. With nearly 100 sites and more than 220 investigators, Velocity partners with pharmaceutical and biotechnology companies to research new drugs, medical devices, diagnostics, and combination products that could improve human health and wellbeing. Velocity offers unified research site solutions to efficiently provide the right patients, investigators, and research staff for clinical trials across the U.S. and Europe.

The company also operates a technology hub in India, where it is unlocking a new era in clinical research by developing innovative systems to leverage expansive site, patient, and historical performance data. To learn more about how Velocity delivers high-quality data, exemplary patient care, and unprecedented efficiency for clinical trials at any scale, visit VelocityClinical.com

About KO-MED KO-MED Clinical Centers is a network of modern and dynamic clinical trial sites that enroll patients from all over Poland into clinical trials. Our mission is to carry out clinical trials that provide patients with an opportunity to regain health and contribute to the development of medicine. We have been running our business for 20 years and have completed hundreds of clinical trials.

About Marek Konieczny, MD, PhD Dr. Konieczny is a specialist in cardiology and internal medicine. He is the founder of the first and largest network of clinical study sites in Poland – KO-MED CK, encompassing both private research facilities within research and teaching hospitals, research institutes, and large hospitals. In developing this network, he drew inspiration from best practices in the United States, visiting numerous research centers. He established collaboration with the Medical College of Wisconsin and has been involved as a principal investigator and co-investigator in over 200 clinical study projects. Recognized for achieving the best recruitment results not only in Poland and Europe but also globally, he has been entrusted with prestigious roles as a national coordinator, earning trust backed by numerous audits and inspections, including those by the FDA, highlighting the highest quality present in KO-MED CK.

About the Pulmonary Research Institute (PRI) The Pulmonary Research Institute at the LungenClinic Grosshansdorf was founded 25 years ago. Under the joint leadership of Dr. med. Anne-Marie Kirsten and Dr. med. Henrik Watz, they have conducted well over 300 studies and their work has been included in over 250 publications. In addition to the core competencies in the COPD area, the Pneumological Research Institute carries out studies in areas such as bronchial asthma, bronchiectasis and pulmonary fibrosis.

Dr. med. Kirsten holds a medical degree from the University of Hamburg with a doctoral thesis focusing on nitric oxide production in human airways. After graduating she worked at the University of Mainz, Dept. of Internal Medicine and became the Head of Pulmonary Research Institute office at Krankenhaus Grosshansdorf. Since 2008 she has been the managing director of PRI.

Dr. med. Watz studied medicine at Justus-Liebig-University, Giessen, Germany, specializing in pulmonary diseases. He gained additional medical qualifications from Kompetenzzentrum für klinische Studien, Bremen and in Düsseldorf. He was a physician at Pulmonary Research Institute at Krankenhaus Grosshansdorf before becoming managing director at PRI in 2008. As a researcher, he has clinical experience in Bronchial carcinoma, healthy volunteers Asthma, COPD, Sarcoidosis, Lung fibrosis.

About KLB Gesundheitsforschung Lübeck Since 2008, KLB Gesundheitsforschung Lübeck GmbH has been conducting clinical studies in the area of ​​basic research and therapy for respiratory diseases in order to research new active principles and diagnostic procedures for bronchial asthma, hay fever, allergies, smoker’s lung/COPD and bronchiectasis.

Dr. med. Andrea Ludwig-Sengpiel is managing partner of KLB Health Research Lübeck. Since 2001, she has conducted more than 180 phase I-IV clinical trials in the indications of bronchial asthma, allergic rhinitis, COPD, sarcoidosis, pulmonary fibrosis, allergic bronchopulmonary aspergillosis (ABPA) and bronchiectasis. She graduated from the University of Hamburg with a medical degree and was a research physician at Pneumologisches Forschungsinstitut am Krankenhaus Großhansdorf before becoming the managing director of KLB.

Recent posts

• Closing the gap: Breaking weight-based stigma in clinical trials June 27, 2024
• Velocity Continues Rapid Growth with Luminis Health Partnership and Expansion into Oncology June 18, 2024
• Dr. Kowdley Makes Significant Contributions to Pivotal Research Program for Ipsen’s Iqirvo for Primary Biliary Cholangitis June 12, 2024
• Velocity Partners with Luminis Health, Moves into Oncology in the U.S. June 12, 2024
• VISION Achieves 2,000 Patient Randomizations June 7, 2024

Quality. Continuity. Velocity.

List of Clinical Research Organizations (CRO) for Clinical Trials in Europe (Part 1)

Patricio ledesma.

Contract Research Organization

24 January, 2024

Contact us at [email protected] if you need CRO services for clinical trials in Europe.

Here you can find a comprehensive list of small and medium-sized European contract research organizations (CROs) specialized in clinical trial management.

These are full service CROs focused on managing phase I-IV clinical trials, including services such as regulatory affairs, site management, monitoring, data management, pharmacovigilance, biostatistics, and medical writing, among others.

The CROs listed are located in EU member states or associated countries, which have been alphabetically ordered.

This list is structured in two parts. The first part of the list (presented in this article) contains the following countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, and Greece.

The second part of the list can be seen in this link , and includes the following countries: Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, and Ukraine.

Clinical Investigation Support (CIS)

CIS is a completely independent, internationally operating contract research organisation. CIS offers consulting services in clinical research and development, in particular in the areas of quality assurance and regulatory affairs. CIS has a documented broad international experience in West and East Europe, but also in non-European countries.

J&P Medical Research

J&P Medical Research Ltd. offers the entire range of clinical research services for phases II-IV. Our interdisciplinary principal investigators and research staff have long-standing expertise in conducting clinical phase II and phase I-IV clinical studies. Our outstanding reputation stems from diligently focusing on planning and conducting scientific studies, pharmacokinetic and statistical analyses, clinical trial monitoring and the preparation of standardized medical documents.

pan Clinical Research Consulting

pan Clinical Research Consulting provides the following services: Clinical trial services and consulting (Phase I-IV), site identification / investigator recruitment, study setup (including investigator / hospital contract management), regulatory authority -and Ethics Committee- submissions, monitoring, project management and resourcing of Clinical Research Associates (CRAs).

Archer Research

Archer Research is a contract research organization dedicated to helping companies and healthcare professionals with their clinical investigations. Our expertise is strongly focused on the medical device industry. Archer Research is located in the heart of Europe with a fast connection between Belgium, France, The Netherlands and Germany.

DICE is a CRO specialized in clinical study design, biostatistics, clinical data management, medical monitoring, medical writing, and central imaging review. Our mission is to enhance access to medical treatment by delivering excellence in the design and execution of clinical trials.

Sillar Clinical

Sillar Clinical is specialized in assisting companies from clinical development strategy to the full setup and management of clinical trials. In parallel we offer GCP auditing services and vendor assessments.

4Clinics is a Contract Research Organization (CRO) providing data management, biostatistics, scientific writing, regulatory affairs and clinical operations services for clinical, observational and epidemiological studies with a particular expertise in vaccines, immunotherapeutics, cell and gene therapies with a dedicated branch for medical devices.

August Research

August Research is a CRO providing the following clinical trial services: study feasibilities and strategy consultation/country selection, regulatory and ethics submissions, site and investigator contract preparations/negotiations, all monitoring and study oversight (during start-up, initiation, maintenance, close-out), local drug and equipment management, project management, clinical study supplies provisioning, site/investigator payments, investigator meeting organization, document archiving, insourcing/ FSP projects, and legal representative services.

Comac Medical

Comac Medical offers a broad range of early to late phase drug development services managed by professionals fully devoted to the clients’ programs and needs. The services can be contracted as part of a full-service integrated program or as stand-alone solutions. We work in partnership with our clients to maximize opportunities, remaining flexible to individual requirements and meeting key milestones on time and on budget.

Convex Clinical Research

Convex is a clinical research services provider in Bulgaria with extensive experience in the management of clinical trials. As a local CRO we deliver high quality clinical trial services in Bulgaria and in other countries in Eastern Europe through our partnering companies. Convex offers a full range of services in clinical study management for: Phase I–IV studies on drugs, bioequivalence and bioavailability studies, clinical studies on food supplements, clinical studies on medical devices, and clinical studies on vaccines.

Ramus Medical

Ramus Medical is a full service CRO established in 2009 by Assoc. Prof. Dr. Rossen Mihaylov, Managing Director and Founder, having its headquarters in Sofia, Bulgaria. The company provides services from protocol development to final report through RA consultancy, clinical monitoring, site management, GxP auditing, bioanalysis (HPLC and LC-MS/MS), statistics and data management.

Marti Farm Ltd, company based in Zagreb, Croatia, is a Contract Research Organization supporting the needs of the pharmaceutical, biotechnology, medical devices, food supplements, cosmetics and healthcare industries across a variety of core services areas. We are internationally recognized as a reliable partner and provider of consultancy and regulatory services across pharmacovigilance, registration and market access, clinical trials, patient support programs and medical writing.

Optimapharm

Established in 2006, Optimapharm is a full-service Contract Research Organization that provides tailored solutions for our clients, and has a high-level of expertise in managing trials across Europe. With unrivalled access to patients in the emerging markets of Eastern and South Eastern Europe, and with strong presence in Western Europe, our operational excellence and customer-focused approach has resulted in our achieving a 95% repeat business level.                 

We are an independent, private company providing high quality clinical trial monitoring services in the South-Eastern Europe region. We provide a full range of activities required for the regular and legal conduct of a clinical trial, including: site selection, feasibility and evaluation; negotiation of contracts with institutions and investigators; regulatory submissions and obtaining of approvals; obtaining import permits and organizing the import of study medication and all study materials; all monitoring activities including Site Initiation Visit, Interim Monitoring Visits and Close-Out Visits; SUSAR reporting; drug safety reporting; 24 hour expert support; communication between trial sponsor and trial site; monitoring (phases I-IV); pharmacovigilance; translation of clinical trial-related documentation; and specialized medical and certified translations.

BECRO is an independent contract services organization (CRO) founded by professionals with research and clinical experience in academia, regulatory authorities and pharmaceutical industry in order to promote excellence in clinical research. Our services include clinical trial monitoring, data management and biometrics, pharmaceutical market research, pharmaceutical advisory boards, and regulatory affairs. 

ClinBAY’s services involve statistical consulting and programming for clinical trials. We manage approximately 40 clinical trials per year, spanning from phase I to phase IV. Our consultants are also available for functional sourcing support in Biometry. Last, we develop custom data analysis packages in R and SAS.

Ilikos Drug Development Solutions

ILIKOS offers comprehensive site evaluation and monitoring services from feasibility through site close-out across North America, Europe and the META (Middle-East, Turkey and Africa) regions. Our monitors have 10+ years of experience on average along with excellent understanding of regulatory guidelines in their region. 

Czech Republic

A-Pharma is a privately owned Czech CRO (Contract research organization) founded in 1996. The company can offer complete services in the field of clinical trials, medical devices, drug registration, data management, biostatistics, quality assurance including GCP auditing, translations of medical text and GCP trainings.

NEOX is a CRO providing drug development, medical device development, pharmacovigilance and regulatory, real world evidence/ data and HEOR, data management and biostatistics, and professional life sciences, medical and regulatory translation services.

Pharmservice

Founded in 2003, Pharmservice is a Clinical Research Organization (CRO) and Pharmaceutical Consulting Company delivering high quality services in the Czech and Slovak Republics. Our clinical research services include start-up and regulatory, clinical trial monitoring, data management and analysis, project management, site contract negotiation, post marketing studies (PMS), regulatory affairs and pharmacovigilance services.

Prague Clinical Services

Prague Clinical Services is a full-service, independent contract research organisation. Our services include clinical operations, regulatory services, medical writing, data management, biostatistics, quality assurance, pharmacovigilance, bridging studies, and medical monitoring. 

Larix is a family founded, privately owned CRO offering full service (statistics, data management, clinical operations, medical writing, pharmacovigilance) solutions. Our offices are located near Copenhagen, in the middle of the Medicon Valley region and we have strong ties to the thriving pharmaceutical and biotech activities in this region. In 2015 Larix expanded to Sweden, Norway and Finland and now ranks as one of the largest local Nordic CROs.

NBCD is dedicated to clinical drug development in osteoarthritis. We specialize in design and execution of clinical trials within both pain and DMOAD compounds for osteoarthritis. We are experts in placebo response mitigation and selecting the right patients. Our background makes us experts in precision medicine using unique biomarker technologies. We support our biotech and pharmaceutical clients advance their osteoarthritis compounds through all clinical development phases.

Qmed Consulting

Qmed Consulting is a global full-service Contract Research Organization (CRO) based in Copenhagen, Denmark. We provide strategic consulting services in connection with medical device approval as well as best-in-class expertise in clinical affairs, regulatory affairs, quality management and commercial healthcare.

Clinical Accelerator

Clinical Accelerator is a clinical CRO and a patient enrollment organization operating since 2006. We also manage a network of investigators and patient referring physicians who are our valuable partners in implementing clinical studies. We place our studies in Central and Eastern Europe, the region with many well documented advantages for clinical trials. As a clinical CRO, Clinical Accelerator offers a full range of clinical trial services from protocol development and regulatory affairs through clinical conduct to data management, biostatistics and study reporting. We have performed numerous projects in all main therapeutic areas, including oncology, CNS, cardiology, pulmonology, GI, dermatology and ophthalmology.

Gaea was established in 1994 as a clinical consultancy to assist in clinical development plans, and to provide project management within Sponsors. Gaea expanded to become a trial enrollment acceleration company working at problematic sites that are common in many trials. In 2010 Gaea became a full-service CRO in Europe, from the UK. In 2018 Gaea exited the UK and moved European trial management to Estonia and Ukraine. Gaea works with difficult to enrol trials and complex IMP in oncology, acute care, intensive care, and neurology. 

AKL Clinical Trials & Consulting

AKL clinical trial services include feasibility studies, site selection and pre-study activities, regulatory and ethics submissions (Finland), budget and contract negotiation support, site initiation and site staff training, site monitoring, site close out activities, and trial management.

Established in 2005, Crown CRO is a privately owned CRO with Finnish roots and a global network. We specialize in customer-oriented, competitive, and flexible services for clinical trials and regulatory affairs in Europe and the United States, serving the pharmaceutical, biotech, functional food, and medical device industries as well as contract research organizations. Our headquarters are located in Finland, and we have a strong presence in Sweden, Denmark, Norway, Estonia, Latvia, and Lithuania.

4Pharma is a contract research organization (CRO) providing medical research services to pharmaceutical, biotechnology, medical device and food companies. Focused on biostatistics, data management and medical writing, 4Pharma employees offer a unique blend of industry experience, service provider flexibility and the academic excellence of truly data driven mindsets.

Biomedical and Global Clinical Solutions

Biomedical and Global Clinical Solutions (BG ClinicalS Ltd) is an independent, privately held Contract Research Organization (CRO) located in southwest France. BG ClinicalS expertise applies to the full process of phase I to III biomedical research studies, from concept to clinical report. BG ClinicalS excellence in trial management addresses most expectations of our customers in pharmaceutical, biotech companies and agro-food/nutraceutical industries.

ClinSearch is a French Clinical Research Organization which provides clinical development and commercialization services for medical device and drug development on a European level. We are committed to offering individualized, cost-effective solutions to managing pre- or post-marketing studies in Europe, as well as obtaining reimbursement in key markets. From developing study methodology, to writing and reviewing study documents, conducting regulatory and site feasibility, adapted electronic data management solutions, monitoring in Europe, producing top-notch study and statistical reports: we have it all under our roof in Malakoff, South-West Paris.

Excelya stands apart from all other clinical development companies working for healthcare businesses. We are the only independent European CRO providing R&D players with full-service offers within a cooperative framework. Our clients can depend on the highest degree of involvement to guarantee the excellence they need. Our customized solutions perfectly match the scope and specificity of our clients’ research projects. We galvanise the finest scientific and human skills to be found in the clinical, biometric, regulatory, medical writing, data science and pharmacovigilance fields.

ExperTrials

ExperTrials is a full-service Clinical Contract Research Organisation (CRO) dedicated to biotech and medtech startups. Our service portfolio includes clinical operations, quality assurance, regulatory affairs, pharmacovigilance and safety, medical monitoring, and vendors management.

Pharmaspecific

Founded in 2010, Pharmaspecific is an ISO9001 certified company located in the Paris region. We are both a CRO and also an SMO (site management organization) in France. Specialists in clinical research, we provide a complete service for the conduct and track of clinical and observational studies. We collaborate with pharmaceutical companies (human and veterinary drugs), CROs, biotechs, clinical sites and medical device companies. 

PopsiCube-Fovea

Popsicube-Fovea is not only a CRO. We act in several collaborative projects in the area of the future of healthcare, like personalized and predictive medicine, and artificial intelligence, where our combined expertise in clinical trials and new technologies have great applications. We provide clinical services, data management, biostatistics, innovative data collection tools, secured gateway, biosensors, and tailor made applications.

CONET GmbH is a privately owned, well established full-service CRO (Contract Research Organization) headquartered in Mannheim, Germany, with a representative office in Moscow, Russia. For more than 14 years, CONET offers clinical trial management service from small pilot studies to large multicenter international clinical trials for all phases (1-4), including pediatric clinical trials as well as IITs and medical device trials in accordance with EU Directives, internationally accepted guidelines and standards, like ICH-GCP or ISO EN 14155 and national laws.

FGK Clinical Research

FGK Clinical Research is a Europe-based CRO of an ideal size for cooperation with smaller and middle-size biotech, pharmaceutical or medical device companies. We currently have 140 employees in-house at our offices – all very experienced in their own fields and trained according to the latest standards in clinical research. Our services include consulting, regulatory affairs, project management / monitoring, data management / biostatistics, pharmacovigilance, medical writing, quality assurance, medical safety, and eSolutions.

Sacura is a full-service contract research organization granting a high level of quality (FDA approved), flexible structures and qualified staff. We are dedicated to the success of our clients by providing extensive support through a network of veterans previously experienced in leading positions in the big pharmaceutical industry to cover the entire life cycle process of your product. We are experts in the set-up, managing and performance of clinical trials. We are experienced in more than 70 indications and more than 130 different studies. 

SCIRENT was founded in 2012 with the vision to help clients develop innovative medical drugs and devices for patients with cardiovascular diseases. Our dedicated team of experienced clinical and regulatory professionals shares your enthusiasm for developing effective therapies for heart patients. What makes us different from our competitors is our profound expertise in cardiovascular therapeutics and diagnostics. Our CRO offers access to an excellent network of dedicated trial sites in Europe and North America with extensive experience in cardiovascular trials.

SSS International Clinical Research

As an internationally operating Clinical Research Organisation (CRO), we have managed clinical trials in almost 20 countries. Starting with quality assurance services back in 1993 we have successfully run more than 250 clinical trials and non-interventional studies to date. Our clients are ‘big pharma’ (4 out of the top ten), biotech, diagnostics and medtech companies. We are a full-service provider covering every aspect of clinical research. SSS International Clinical Research is DIN EN ISO 9001:2015 certified.  

ANTAEA is one of the largest regional Contract Research Organizations (CROs), providing high quality services in South-East Europe, Middle East and Africa with coverage in Greece, Cyprus, Egypt, Lebanon, Jordan, Tunisia, Morocco, Gulf states, Saudi Arabia, Sudan and Ghana. Since 1998, we provide professional flexible solutions supporting our clients to optimize allocation of their research resources achieving timely results in a cost effective manner. ANTAEA is committed to deliver services of scientific quality, management expertise, and precision based on reliable technologies. To date, we have performed over 520 clinical trials and over 1900 Registration & Regulatory submissions

Operating for more than two decades in Greece and Cyprus, CORONIS has been delivering a full spectrum of services to national and international pharmaceutical, biotechnology and medical device industries and other healthcare-related organisations. The configuration of our services has followed our customers’ demands and has been built according to the following main categories: clinical development, real world data, commercialization, regulatory affairs, vigilance, training and learning.

Health Data Specialists (HeaDS) is a full-service European Contract Research Organization (CRO) dedicated to the conduct of clinical studies, with particular expertise in hemato-oncology studies. We provide the complete range of clinical trial services, from start-up to completion, from Phase I to IV. In addition, we provide strategic oncology drug development consulting and expert advice as we understand the challenges of developing anti-cancer drugs in the complex, highly competitive and rapidly developing oncology market.

NEXT CRO is a highly added value, Contract Research Organisation (CRO), running Clinical Trials in Greece, Turkey and Cyprus, and with its alliances, globally, offering “plug and play” study teams. NEXT CRO provides added value clinical trial services in all therapeutic areas, including rare diseases.

ZEINCRO is a contract research organization (CRO) that provides its services to more than 21 countries in Europe, with special focus on the region of Central and South-Eastern Europe. ZEINCRO provides clinical trial services to the global drug development industry and offers additional services in the areas of post-marketing safety and efficacy studies, regulatory affairs and pharmacovigilance (IRISG), Phase I studies, including risk management plans.

Click here to see the second part of this CRO list.

Patricio Ledesma ( B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266   [email protected]  

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Patricio Ledesma ( B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  [email protected]  

Faster access to clinical trial information in Europe

The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European Union (EU) for patients, healthcare professionals and other stakeholders. This is due to the revised transparency rules that become applicable today in Europe.

One of the key changes is earlier availability of information on authorised clinical trials. Importantly, the new rules eliminate the previously available deferral mechanism, which allowed clinical trial sponsors to delay publishing certain data and documents for up to seven years after a trial’s completion to protect commercially confidential information. Under the new rules, approximately 4,000 clinical trials with issued decisions are now publicly accessible through the CTIS search . The CTIS portal will add approximately 500 newly authorised clinical trials per month. This includes ongoing trials that have been transitioned to CTIS from the Clinical Trials Directive. Over the next few months, additional features will be added to the CTIS public portal to further enhance overall usability.

The updated rules strike a balance between transparency of information and protection of commercially confidential information. They benefit patients, because key clinical trial information, that patients flagged as being most relevant for them, is published early. They also benefit clinical trial sponsors because they introduce process simplifications. Finally, they benefit healthcare professionals because the resulting system is more user-friendly, facilitating access to information on clinical trials and enrolment in clinical trials, and also increasing awareness of possible treatment options.

Several resources have been created to help sponsors understand the revised transparency rules, including a user guide and an overview of which data and documents with key information will be published. Dedicated support activities are also being organised, starting with an event on 20 June open to all sponsors of clinical trials including pharmaceutical companies, contract research organisations, small and medium-sized enterprises and academic organisations.

The revised transparency rules were  adopted by EMA’s Management Board in October 2023 following a  public consultation held between May and June 2023.

CTIS is the single-entry point for the submission and assessment of applications for clinical trials in the EU for sponsors and regulators. The system includes a public searchable database for healthcare professionals, patients and the general public to deliver the high level of transparency foreseen by the regulation. The authorisation and oversight of clinical trials is the responsibility of EU/EEA Member States while EMA is responsible for maintaining the CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation .

Related documents

Revised CTIS Transparency Rules

English (EN) (377.41 KB - PDF)

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List of Contract Research Organizations in Spain

Featured cros.

Celero provides optimal returns to innovative biotechs & pharmaceutical companies by addressing unmet needs, accelerating clinical development and commercialising innovative healthcare products.Trial mismanagement is the main reason why 85%-90% o...

SanaClis is a full-service Global CRO with a fully integrated clinical supply chain, thereby offering a comprehensive range of end-to-end services for clinical trials. SanaClis was founded in 2000 by seasoned industry experts, all of whom have had ex...

Founded by a group of highly qualified people with a vast experience in CROs and pharmaceutical companies, APICES is a company with Spanish identity and an international vocation. APICES is not only a CRO, but a Company giving an added value to custo...

Pivotal was born back in 2001 on the principle that strategic scientific and medical advice and support should be the backbone of all clinical trials and with the objective of becoming a reliable full-service CRO with proper and suffic...

Local, small- and mid-size Contract Research Organizations in Spain

Alpha Bioresearch is a Full Service CRO with more than 25 years leading projects in Europe and specialized in Spain & Portugal markets. We combine the agility and flexibility of a local CRO, with the coverage of a global CRO and our work is mainl... View full profile

Located in Barcelona (Spain) Anapharm Bioanalytics is a customer-focused bioanalytical contract research organization (CRO) supporting pharmaceutical development from early preclinical through late stage clinical research contributing to the approval... View full profile

Founded by a group of highly qualified people with a vast experience in CROs and pharmaceutical companies, APICES is a company with Spanish identity and an international vocation. APICES is not only a CRO, but a Company giving an added value to custo... View full profile

BioClever is a full service CRO, dynamic and reliable that offers comprehensive support in clinical research activities. We are committed to help our clients to accelerate the development of drugs and devices that save lives and improve quality of li... View full profile

GenesisCare Clinical CRO is an independent company founded by GenesisCare, with people skilled across the full spectrum of traditional CRO service offerings yet connected through GenesisCare to additional research services and investigator sites. Why... View full profile

• United Kingdom
• United States

O IATec é um instituto que dedica seus esforços em um único objetivo: unificar e apoiar a estrutura da Igreja Adventista do Sétimo Dia em suas rotinas administrativas, através de soluções em TI. View full profile

Linical was established in June 2005 by a group of professionals who were engaged in new drug development at a major Japanese pharmaceutical company. Ever since, in accordance with our philosophy of contributing to new drug development and promoting... View full profile

Sofpromed is a full service Clinical Research Organization (CRO) specialized in the global management of phase I-IV clinical trials worldwide for biotechnology and pharmaceutical companies across all therapeutic areas. We manage clinical trials glob... View full profile

Global Contract Research Organizations in Spain

Axonal-Biostatem has been delivering top-notch management of clinical and epidemiological research projects in France and Europe for more than 30 years. Axonal-Biostatem is a full service CRO providing all services internally and able to integrally p... View full profile

A global, full-service contract research organization. We take your trials personally. dMed Global, a full-service Clinical Contract Research Organization (CRO) based in Shanghai, China and Clinipace Incorporated, a full-service Clinical CRO with hea... View full profile

• Czech Republic
• South Korea
• Switzerland

Celero provides optimal returns to innovative biotechs & pharmaceutical companies by addressing unmet needs, accelerating clinical development and commercialising innovative healthcare products.Trial mismanagement is the main reason why 85%-90% o... View full profile

• Netherlands
• Philippines
• South Africa

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guides us in all that we do, and we approach each day with the knowledge that our work h... View full profile

Established in 1995, Dokumeds has been expanding its coverage and services significantly over 25 years of operations. Gradual geographical and operational coverage expansion correlated with company staff growth and lowering of employee turnover to an... View full profile

Founded in Prague in 2004, EastHORN Clinical Services is today one of the leading CROs in Europe. We operate in over 20 countries in the region with an experienced team comprised largely of physicians and PhDs. EastHORN’s client-base ranges from the... View full profile

As a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions and other enabling services, Fortrea partners with emerging and large biopharma and medical device and diagnostic companies t... View full profile

• New Zealand

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We are a global provider of consulting, and outsourced developme... View full profile

IMS Health and Quintiles are now IQVIA, a world leader in using data, technology, advanced analytics and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, m... View full profile

• Bosnia & Herzegovina

Keyrus Life Science is the C2RO launched by the Keyrus Group, the “Making Data Matter” company. Keyrus Life Science is a unique Connected Clinical Research & Development Organization. Keyrus Life Science helps connect industry expertise, Life Da... View full profile

Our unique global partnering philosophy emphasizes an uncompromising commitment to clinical research and to the highest level of ethical standards and performance in our jobs. We are selective about the projects we engage in because we are devoted to... View full profile

OPIS was founded in 1998 as a small Italian CRO. Over the past 20 years we have worked with passion and dedication to conquer the trust of clients and the scientific community, learning from each project and challenge convinced that investing in know... View full profile

For over 35 years, PAREXEL has proven to be a trusted partner for the complex development journey required of biopharmaceutical and medical device companies. We’re also an astute guide, able to simplify that journey for our clients, so safe new produ... View full profile

Pivotal was born back in 2001 on the principle that strategic scientific and medical advice and support should be the backbone of all clinical trials and with the objective of becoming a reliable full-service CRO with proper and sufficient resources... View full profile

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and go... View full profile

Our mission is to be the best CRO in the world as measured by our employees, clients, investigators, and vendors. Our teams work tirelessly to ensure that we deliver on time and on budget. You will always know what's going on with your study when you... View full profile

Rede Optimus is a medical device CRO with a global outreach to USA, EU and Brazil. Rede Optimus was founded by a group of  physicians dedicated to the medical device field which focusses on collaborative research and traditional CRO work. With our fo... View full profile

RTI Health Solutions is the place you turn when you need substantiated, authoritative evidence and advice. We are scientists first—academically-trained, credentialed researchers who know how and when to apply the appropriate research methodologies to... View full profile

SanaClis is a full-service Global CRO with a fully integrated clinical supply chain, thereby offering a comprehensive range of end-to-end services for clinical trials. SanaClis was founded in 2000 by seasoned industry experts, all of whom have had ex... View full profile

Life sciences services from SGS – optimize your development timelines to get medicines and medical devices to market quickly and safely. There is no other area of business that is more heavily regulated than the development, testing and distribution... View full profile

• Burkina Faso
• Congo, DR of
• Cote d'Ivoire
• Dominican Republic
• El Salvador
• Equatorial Guinea
• Papua New Guinea
• Saint Lucia
• Saudi Arabia
• Trinidad & Tobago
• Turkmenistan

Syneos Health (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs a... View full profile

List of CROs by location

• United Arab Emirates

A Turkish company specializing in clinical and preclinical research solutions for the medical and medical device sectors is seeking international partners for collaboration through commercial and outsourcing agreements.

General information, partner sought, dissemination.

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SME definition

Small and medium-sized enterprises (SMEs) represent 99% of all businesses in the EU. The definition of an SME is important for access to finance and EU support programmes targeted specifically at these enterprises.

What is an SME?

Small and medium-sized enterprises (SMEs) are defined in the EU recommendation 2003/361 .

The main factors determining whether an enterprise is an SME are

• staff headcount
• either turnover or balance sheet total

These ceilings apply to the figures for individual firms only. A firm that is part of a larger group may need to include staff headcount/turnover/balance sheet data from that group too.

Further details include

• The revised user guide to the SME definition (2020) (2 MB, available in all EU languages)
• Declaring your enterprise to be an SME (the form is available in all languages as an annex in the revised user guide)
• The SME self-assessment tool which you can use to determine whether your organisation qualifies as a small and medium-sized enterprise

What help can SMEs get?

There are 2 broad types of potential benefit for an enterprise if it meets the criteria

• eligibility for support under many EU business-support programmes targeted specifically at SMEs: research funding, competitiveness and innovation funding and similar national support programmes that could otherwise be banned as unfair government support ('state aid' – see block exemption regulation )
• fewer requirements or reduced fees for EU administrative compliance

Monitoring of the implementation of the SME definition

The Commission monitors the implementation of the SME definition and reviews it in irregular intervals. Pursuant to the latest evaluation, the Commission concluded that there is no need for a revision.

On 25 October 2021, we informed stakeholders by holding a webinar with presentations on the SME evaluation's results and next steps.

Supporting documents

• Study to map, measure and portray the EU mid-cap landscape (2022)
• Staff working document on the evaluation of the SME definition  (2021)
• Executive summary on the evaluation of the SME definition  (2021)
• Q&A on the evaluation of the SME definition  (2021)
• Final report on evaluation of the SME definition  (2018) (10 MB)
• Final report on evaluation of the SME definition (2012)  (1.8 MB)
• Executive summary on evaluation of the SME definition (2012)  (345 kB)
• Implementing the SME definition (2009)  (50 kB)
• Implementing the SME definition (2006)  (40 kB)

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