clinical research companies toronto

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List of Contract Research Organizations in Canada

Featured cros.

iNGENū is the FDA-centric Australian CRO championing disruptive, innovative biotech firms globally. Our core mission is to create access to high quality clinical research globally, for early to mid-stage biotechs by removing financial and other unnec...

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...

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

Allphase Clinical Research is a full-service, progressive, Contract Research Organization (CRO) providing high quality clinical development strategy and management services for early-stage to post-market programs. Allphase was founded with the mandat... View full profile

• United States

Welcome to the Biotrial website, where you will find extensive information on the services we offer, on our expertise and experience, and of course on how to contact us. At Biotrial, drug evaluation and pharmacology research is a tailor-made service.... View full profile

• United Kingdom

Canadian Centre for Clinical Trials is a contract research organization with more than a decade of experience, qualified experts, a personalized approach, and competitive prices. We will provide all tools to support your clinical trial all the way. I... View full profile

CMX Research Inc. collaborates with an elite portfolio of clients. They range from domestic and large global Pharmaceutical organizations, emerging Biotech firms and Device companies.CMX is a niche CRO that started as a Site Management Organization (... View full profile

Ethica CRO Inc. is a full-service Contract Research Organization (CRO) that conducts and manages ethical clinical research on drugs, biologics, medical devices and natural health products. Canadian life sciences companies pursuing market expansion t... View full profile

Innovaderm shares your mission of developing innovative treatments for patients living with skin diseases. With in-depth therapeutic expertise and our focus on dermatology, we are committed to the clinical development of the next generation of dermat... View full profile

JSS Medical Research is a full-service CRO built on a foundation of epidemiological and scientific expertise, with a strong network of academic affiliations and over 30 years of experience in multiple therapeutic areas. We are an international Canad... View full profile

Syreon is an expert contract research organization conducting international clinical trials, health economics and outcomes research, computational analysis and real-world evidence research across a broad range of chronic and complex diseases. Our par... View full profile

We are TRIO, a not-for-profit academic clinical research organization (CRO). We are academic leaders in our field and share your goal to find the shortest path to saving lives. With a worldwide network of over 700 cancer centres, we can deliver accur... View full profile

Vantage BioTrials is a Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services to international pharmaceutical, biotechnology, generic pharmaceutical and medical device companies. We believe that success is... View full profile

Global Contract Research Organizations in Canada

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and an... View full profile

With 15 years of experience, we have defined a process that consistently achieves success for our clients.RESEARCH that uncovers the real needs and delivers actionable insights.At the heart of any healthcare challenge lies a compelling narrative. To... View full profile

• Switzerland

Cato Research is a contract research organization (CRO) that provides integrated services to pharmaceutical, biotechnology, and medical device companies. We specialize in complex development programs requiring innovative regulatory and clinical strat... View full profile

Celerion, a leader in early clinical research, delivers Applied Translational Medicine. In Applied Translational Medicine, Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug a... View full profile

• South Korea

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

Address: 603-7 St Thomas Street Toronto, ON M5S 2B7, Canadadicentra is a full-service Contract Research Organization (CRO) and professional consulting firm that specializes in addressing all matters related to safety, quality, and compliance for all... View full profile

Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. With a presence on six continent... View full profile

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

• Czech Republic
• New Zealand

iNGENū is the FDA-centric Australian CRO championing disruptive, innovative biotech firms globally. Our core mission is to create access to high quality clinical research globally, for early to mid-stage biotechs by removing financial and other unnec... 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

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

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

Novum Pharmaceutical Research Services

Global footprint, vast therapeutic expertise and seamless execution, latest news.

Meet us at CPHI Milan 2024

Message from the Managing Director’s Desk

At Novum Pharmaceutical Research Services, our dedicated focus revolves around providing comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. We consistently set new standards in the clinical research sector, achieving milestones through both organic growth and strategic acquisitions.

In 2019, Lambda Therapeutic Research strategically expanded its North American presence by acquiring Novum Pharmaceutical Research Services, a distinguished 50-year-old CRO. This strategic move, following the integration of Biovail’s R&D facilities in Canada in 2010, marked Lambda’s second significant acquisition in North America. Operating under the unified brand of Novum Pharmaceutical Research Services in North America, Lambda reinforces its position as a key player in the global CRO market.

Leveraging the trusted Novum brand, we are committed to delivering a seamless and enhanced suite of services across our North American operations. Over the past years, we have upheld an impeccable regulatory track record, successfully navigating various international inspections across our global units. We have also bolstered our clinical trial management capabilities by investing in top-tier scientific talent and expanding our global network of clinical sites. Our dedication to exceeding client expectations is unwavering, as we continue to offer a comprehensive portfolio of early and late-phase services.

With a focus on integrity, innovation, and client satisfaction, we are confident that our efforts will continue to meet and surpass client expectations, always

Bindi Chudgar Managing Director

​Turnkey Clinical Trial Management solution for YOUR drug development programs

Guided by a senior management team with expertise in science, operations, quality assurance, medical affairs and project management, Novum offers the highest levels of integrity and reliability.

Phase I Early Clinical Development

Phase II-IV Clinical Trial Management

Scientific Affairs

Bioanalytical

Nearly fifty years of high-quality research outcomes.

Novum is a full-service CRO with an impeccable performance record and numerous FDA approvals in new drug, 505(b)(2) and ANDA submissions. We manage complex studies across numerous therapeutic areas and dosage forms, spanning early phase to late phase trials. With the full integration of our bioanalytical unit in Toronto, Canada in 2020, Novum is poised to continue its longstanding tradition of serving clients with safety, quality, and scientific leadership.

There are plenty of ways to get in touch. Just select the one that is best for you.

Novum prides itself on its talented and dedicated team of employees. The Novum team is passionate about customer satisfaction, safety and study integrity. All Novum clinical staff members receive extensive training designed to continually hone and increase the skills of each employee.

Want to participate in a study?

Last year we paid over $6.6 million to participants of our research studies.

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One of the largest clinical research networks in North America

One of the largest clinical, research networks in, north america.

With sites across the US and Canada, chances are we’re in your neighborhood.

Featured News

Centricity Research acquires North Carolina-based Lucas Research, expanding its foothold across North America and its wide range of therapeutic area capabilities.

Join a paid clinical research study today.

FDA & Health Canada Drug Approvals

Studies Completed

Therapeutic Areas

Patients Served

Help us end illness and change lives.

When you participate in a clinical study , you help us collect valuable information that aids in the development of new treatments and medications.

Even your favorite pain relievers, morning vitamins, and common antibiotics were made possible because of clinical research!

Explore our open studies and learn how you can get paid to participate.

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Capabilities

Our capabilities extend across the entire spectrum of clinical research services, providing end-to-end solutions for the successful development of your innovative therapies.

Strategic Product Development & Consulting

• Early development and innovation

Phase II-IV Clinical Trial Management

• Clinical Development Services (CDS) Project Management
• Regulatory Affairs
• Medical Writing
• CDMO Services
• Biostatistics & Data Management
• Medical Affairs

Clinical Safety & Pharmacovigilance

• Medical Imaging
• Quality Assurance

Meeting MI & PV Obligations for a COVID-19 Vaccine

AI in Clinical Trial: Present and Future

Therapeutic Expertise

Empowering innovation and advancing vital therapies across diverse therapeutic areas, with extensive experience supporting over 265+ clinical trials across 15+ therapeutic domains.

• Oncology & Hematology
• Dermatology
• Neuroscience
• Biosimilar Development
• Infectious Disease
• Pulmonology
• Cardiovascular & Metabolic disorder
• Gastroenterology
• Ophthalmology
• Musculoskeletal

Cross-Therapeutic

Overcoming Challenges in a Multicenter Oncology Clinical Trial

From Logistics to Seamless Analysis : Enhancing Medical Imaging

Advancing Breast Cancer Research

Advancing Pediatric Clinical Trials

Our Presence

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• Life at Lambda

Lambda Therapeutic Research wins back-to-back global awards

Lambda's BA-BE Centre in India Successfully Passes GCC Inspection..

Lambda Therapeutic Research - Latest Newsletter

Lambda Therapeutic Research Newsletter - August 2023

Full-Service Excellence in Clinical Research

Scientific Proficiency at the Core of Trials

Transcending Global Boundaries

Paving the Path to Regulatory Success

Offering decades of clinical research expertise, global compliance, and therapeutic experience to ensure your promising therapy isn’t delayed by risk or limited resources.

Full-service Excellence in Clinical Research

End-to-end solutions, from early-phase trials to post-marketing studies. Partner with us for comprehensive solutions that drive your success.

Empowering Innovation and Advancing Vital Therapies Across Diverse Therapeutic Areas, with Extensive Experience Supporting Over 280+ Clinical Trials across 15+ Therapeutic Domains .

With locations across the globe, we facilitate global trials with a localized touch, reducing time-to-market and ensuring broad accessibility.

Honored with CPHI Pharma Awards 2023 for Regulatory Excellence , we expertly navigate the Regulatory landscape, for Swift Approvals and Compliance, leveraging our proven track record.

We combine full-service capabilities and global reach to support biotech and pharmaceutical companies with tailored clinical development and resource solutions

Early Development and Innovation

Clinical development services (cds), biostatistics and data management, medical & scientific writing, quality assurace, therapeutic excellence.

Advancing vital therapies across diverse therapeutic areas

• Infectious Disease & Vaccines

Cardiovascular & Metabolic Diseases

Accelerating Biosimilar Development

Lambda proudly holds a legacy of excellence in biosimilar development, spanning a diverse spectrum of renowned molecules including Adalimumab, Bevacizumab, Teriparatide, and numerous others.

End-to-End Solutions

Full-service offerings from Preclinical to Regulatory Support

Analytical Excellence

State-of-the-art lab with ELISA, ECLIA, IVD, Flow Cytometry & More

Why Lambda?

We combine the full-service capabilities and global reach to support biotech and pharmaceutical companies with tailored clinical development and resource solutions.

A Truly Global CRO with Multi-continental Presence

Comprehensive clinical research services, best credit rating in cro industry, strong leadership with 20+ years of experience.

‘Regulatory & Compliance Excellence Award’ at the CPHI Pharma Awards 2023 for the exceptional work by Lambda in ‘Enhancing Compliance & Data Generation in Clinical Trials through Advanced Software Solutions and EDC Platform.’

‘Industry Partner of the Year’ Award

Global generics & biosimilar awards 2023, globally recognized for research excellence.

‘Regulatory & Compliance Excellence Award’ at the CPHI Pharma Awards 2023 for exceptional work in ‘Enhancing Compliance & Data Generation in Clinical Trials through Advanced Software Solutions and EDC Platform.’

‘Industry Partner of the Year’ at the Global Generics & Biosimilars Awards 2023, recognising our innovative testing methods for biosimilars, novel approaches, and commitment to exceeding regulatory expectations from esteemed global agencies like the USFDA & EMA.

Featured Research and Insights

• November 30, 2023

Advancing Breast Cancer Research – Lambda & Novum’s Commitment to Patient-Centric Trials

• October 9, 2023

Advancing Pediatric Clinical Trials:

• August 12, 2023

Overcoming Challenges in a Multicenter Oncology Clinical Trial: Study on Bioequivalence Assessment of Doxorubicin Hydrochloride Liposome Injection

• August 6, 2024

Lambda Achieves successful NPRA Accreditation for Mehsana & Ahmedabad Facilities – July 2024

• July 25, 2024

Audit and Inspection Readiness: A Comprehensive Approach

• July 23, 2024

Advancing Optical Coherence Tomography (OCT) Imaging in Ophthalmic Studies

• July 1, 2024

Choosing the Best CRO for your Clinical Research Project: Key Factors to Consider

• June 28, 2024

Dual Success Across Time Zones: Successfully Supported MHRA and FDA Inspections for Pharmacovigilance Services

• June 26, 2024

Navigating Challenges in a Single-Dose Study to Evaluate Pharmacokinetic and Immunogenicity Endpoints of a Recombinant Humanized mAb

We are aggressively expanding globally and are confident in our research initiatives, propelling us toward a trajectory of excellence.

Corporate Office – Ahmedabad

Lambda House, Plot No. 38, Survey No. 388, Near Silver Oak University, S.G. Highway, Gota, Ahmedabad - 382481, Gujarat, India.

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Lambda Therapeutic Research is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Warsaw (Poland) and London (UK), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

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5 Biotech Companies in Toronto to Know

Biotech companies in Toronto are using technology to advance medical treatment and diagnoses.

The biotech field applies disciplines like data science and artificial intelligence to make biological advancements. In Canada, businesses that operate in this space focus on using technology in the creation of pharmaceuticals, medical devices, diagnostics and other healthcare products. Here are the biotech companies in Toronto leading the way on clinical research and trials for the development of treatments and technologies to address conditions in areas such as neurology and oncology.

Top Biotech Companies in Toronto

Deep genomics, centricity research, geneseeq technology, bluerock therapeutics, biotech companies in toronto to know.

Avicanna is a biopharma company that researches and develops cannabis-based products for consumers and the pharmaceutical cannabis market. It handles clinical development and has brought over 30 products to market in the medical cannabis, cosmetics, wellness and pharmaceutical ingredients spaces.

Avicanna Is Hiring | View Open Jobs

Deep Genomics uses artificial intelligence to power drug research and development with a focus on RNA therapies, which can be programmed to treat specific genetic causes of diseases and medical conditions. The company’s AI system is trained on massive data sets that would be too large for humans to analyze. It mines that data for potential therapeutics.

Deep Genomics Is Hiring | View Open Jobs

Keep Reading Top Tech Companies in Toronto to Know

Centricity Research is an Integrated Research Organization. Its studies and clinical trials cover pharmaceuticals, medical devices and biotechnology. Across more than 35 global sites and over 150 active investigators, Centricity’s research network has access to nearly 8 million patients throughout Canada and the United States.

Centricity Research Is Hiring | View Open Jobs

Geneseeq Technology is a biotech company that applies genomic profiling to precision oncology treatment. It connects cancer patients with genomic testing, treatment matching and clinical development of new therapies. The company specializes in In Vitro Diagnostics, or IVD, which looks at specimens from a patient’s blood or tissues to gather data for screening, diagnosis and treatment. 

Geneseeq Technology Is Hiring | View Open Jobs

BlueRock Therapeutics works to engineer cell therapies. Cell therapy replaces sick or damaged cells with new, healthy cells within specific locations of the human body, or uses immune cells to remove cells that cause disease. BlueRock has studies that focus on cellular treatments for Parkinson’s disease.

BlueRock Therapeutics Is Hiring | View Open Jobs

Rose Velazquez contributed reporting to this story.

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Corporate Overview

A center of excellence for what we do.

Biostatistics and Statistical Programming

Clinical Data Management

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Interactive Response Technologies (IRT)

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Medical and Scientific Writing

Clinical Pharmacology and Drug Development

Regulatory Consultation and Submissions

Functional Service Provider (FSP)

Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been a CRO since January 2004 with a strong foundation as a statistical, programming, and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Headquartered in Toronto, Canada, with subsidiary offices in New Jersey, USA; Shanghai, China; Taipei, Taiwan; Bulgaria, Poland, and Romania in Europe. Everest continues to deepen capabilities and serve highly satisfied customers in data/analytics services and full-service execution with quality, effectiveness, and agility for worldwide clinical trials.

Growing steadily over 20 years, Everest is a preferred vendor for 100+ active clients, including major, mid-sized, and small pharmaceutical, biotech, and medical device companies. We value our clients and all growth to date is primarily from their repeat and referral business. We are known for our high-touch approach with client teams, high quality standards, customer-focus, “can-do” culture, advanced technology utilization, and continuous improvement. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength...that’s us…that’s Everest.

Our Mission and Story

Our mission is to provide outstanding quality, on-time delivery, and exceptional customer service to our clinical research partners.

Company Highlights

• Created by a group of former colleagues of Pharmacia Corporation, Everest has been an independent CRO since 2004 following Pfizer’s acquisition of Pharmacia.
• Successfully operating for over 20 years as an independent CRO, building preferred vendor relationships with a list of global major pharmaceutical companies and over 90 mid-sized and small pharmaceutical, biotechnology, and medical device companies.
• In December 2022, Everest acquired Brightech International, a New Jersey-based CRO that specializes in Biometrics services. Brightech was founded in 2004 and successfully operated for over 19 years as an independent CRO prior to Everest’s acquisition.
• In November 2023, Everest acquired August Research, a European CRO that provides Clinical Operations and Pharmacovigilance services to a wide variety of pharmaceutical and biotechnology clients. August Research has its corporate headquarters located in Sofia Bulgaria, with clinical operations capabilities in North America, Eastern and Western European countries. August Research was founded in 2012 and successfully operated for over 11 years as an independent CRO prior to Everest’s acquisition.
• Growing steadily over 20 years, Everest is a preferred vendor for 100+ active clients.
• A growing company with over 700 full-time staff members and a resource pool of part-time and contract-based consultants.
• All company growth to date is primarily based on repeat and referral business from our satisfied clients.
• Known for a high-touch approach with client teams, high quality standards, customer-focus, “can-do” culture, utilizing advanced technologies, and continuous improvement.
• A proven history of stable workforce through high quality standards for talent recruitment and strong staff retention measures.
• Offers quality and timely services at competitive rates.
• Continues to deepen capabilities and serve highly satisfied customers in data/analytics services and full-service execution with quality, effectiveness, and agility for conducting worldwide clinical trials.

Latest News

Press Release – Acquisition of August Research

Press Release – Acquisition of Brightech International

Access clinical trial data visualizations through our Clinical Data Dashboard

We are ready for an accelerated growth in 2021 and years beyond!

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Clinical Research in Canada

• RocheProPlus

Over the last 40 years, we — as a society — have seen incredible progress in the way illnesses, such as cancer are treated.  We owe these advances to medical research and the millions of patients who have volunteered to participate in clinical trials. As one of five global pharmaceutical Product Development sites, we contribute to all phases of clinical trial development, including overseeing clinical studies in Canada, the US and around the world.

In 2019, Roche invested more than $57 million in clinical research in Canada through 174 Roche-sponsored clinical trials, which offer people with a variety of medical conditions an opportunity to participate in the development of potential new treatment options.

Clinical trials are an integral part of a new drug or diagnostic discovery and development process as they provide evidence about the safety and efficacy of a medicine or diagnostic.  They also provide important information about cost-effectiveness, clinical value, and impact on a patient’s quality of life.

Clinical research follows strict scientific standards to protect patients and help produce reliable study results. Studies are that are carefully designed to answer certain questions while taking steps necessary to safeguard the people taking part in the research. Medicines are usually tested in three phases before regulatory agencies consider them to be safe and effective.

The process can take upwards of 10 years, and according to the an by the Tufts Center for the Study of Drug Development, the average cost to develop and gain marketing approval for a new drug is around $3.9 billion CAD.

The Mississauga pharmaceutical Product Development site participates in patient-centric practices aimed at making trials more accessible and understandable to patients.  Our study management teams have embedded patient-focused practices into the design and execution of our clinical trials, which have included the use of mobile home nurses who help increase trial participation for patients who are unable to come to regular site visits, as well as equipping patients with computers and tablets that disclose key study information related to their trial.

To learn more about clinical trials or to find a Roche-sponsored study, visit our 

Roche believes that improving health outcomes for all patients is core to our mission, and we are committed to being industry leaders in delivering improved health outcomes for all.

In the increasingly diverse world around us, the time is now for research and clinical development to ensure greater inclusion of patients across racial and ethnic groups in support of optimizing health outcomes for all patients worldwide.

Because disease outcomes and drug responses can vary across populations, research must include patients who are racially, ethnically, and gender representative of those who experience disease. Roche is deeply committed to addressing barriers to clinical trial participation, diversifying genetic data for scientific discovery, and increasing access to innovative diagnostic and therapeutic solutions, by advancing inclusive research.

By building trusted partnerships with patients, providers and across the healthcare ecosystem, we can collectively combine scientific advances, new technologies and real-world data to drive scientific innovation and create new standards for inclusive research.

As we strive to deliver more patient benefit, we are passionately addressing healthcare disparities in order to deliver ever more personalized healthcare solutions for all patients.

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BioPharma Services is a full service CRO that can help you take your compound from the protocol development stage right through to submission to regulatory agencies.

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Clinical Trials Ontario

Fuelling a thriving clinical trials sector.

Clinical Trials Ontario is a non-profit organization dedicated to strengthening, promoting and capitalizing on Ontario’s competitive advantages for conducting high-quality clinical trials.

How we support the clinical trials community

Streamlining research ethics reviews, getting trials started faster, navigating ontario's clinical research ecosystem, mentorship for the research community, engaging patients & the public in research.

increase in number of active clinical trials since 2012

Ontario is Canada’s leading trials sector

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• July 3, 2024
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• May 20, 2024

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High-Quality, Patient-Centric Clinical Studies

Top rated clinical trials conducted in a private and comfortable setting to advance health and medical care.

Our Current Trials

We are currently conducting the following trials

A decentralized study

Severly active phase II/III

Ulcerative Colitis

Mild to moderate phase II

Prevent migraine in subjects Age 6-17 years

Blood draw study

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Canadian life science clinical research and manufacturing capabilities.

An important trend in the global pharmaceutical industry over the last decade has been to externalize drug R&D programs and manufacturing, including via partnerships with academia, small and medium sized enterprises ( SME s), government research centres as well as specialized research and manufacturing organizations. As part of this trend, Contract Research Organizations ( CRO s) and Contract Manufacturing Organizations ( CMO s) have become an essential part of the life science value chain, by offering comprehensive services to speed up product development plans and increase manufacturing efficiency. It is estimated that 60% of innovator small molecules and 82% of innovator biologics have their roots in research carried out outside of big pharmaceutical companies over the past decade, with manufacturing and service organizations playing an increasingly important role in supporting the growth of emerging biotechnology companies in areas that include stem cell research and engineering biology, and by providing essential support in meeting stringent regulatory reviews. This profile of Canadian CMO s and CRO s provides an overview of the services of a few select Canadian organizations.

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Multispecific antibodies market research, drug sales, price & clinical trials insights 2023-2029: 13 approved, 900 multispecific antibodies in clinical trials by company, country, indication, & phase.

Dublin, Aug. 09, 2024 (GLOBE NEWSWIRE) -- The "Global Multispecific Antibodies Market, Drug Sales, Price & Clinical Trials Insight 2029" report has been added to ResearchAndMarkets.com's offering.

The market for next generation multispecific antibodies represents an exciting frontier in biotechnology and pharmaceutical development, offering significant opportunities for innovation and growth. These engineered proteins, capable of binding to two or more different targets simultaneously, are revolutionizing therapeutic approaches, especially in oncology. The field has rapidly evolved from the traditional bispecific antibodies to more complex trispecific and tetraspecific constructs, each offering unique advantages in targeting multiple disease pathways or enhancing immune responses against cancer cells.

Currently, bispecific antibodies dominate the approved next generation multispecific antibodies landscape, with 13 products having received regulatory green light around the globe. This initial success has paved the way for more complex multispecific antibodies, highlighting the potential for further market expansion. The market for these innovative therapies crossed a significant milestone in 2023, surpassing US$ 8 billion in global sales. This impressive figure underscores the growing acceptance and demand for multispecific antibodies in clinical practice, particularly in oncology, where they have shown impressive efficacy and safety profiles.

The primary application of next generation multispecific antibodies has been in cancer treatment where they have demonstrated the ability to improve upon traditional monoclonal antibody therapies. For example, bispecific T-cell engagers (BiTE), like Tarlatamab, used in the treatment of small cell lung cancer, simultaneously bind to CD3 on T cells and DLL3 on tumor cells, effectively bringing cancer cells and effector cells in close proximity. This mechanism has shown impressive results in this rare, fast-growing lung cancer. Other examples include Epcoritamab for diffuse large B-cell lymphoma and Talquetamab for multiple myeloma, both leveraging bispecific technology to enhance anti-cancer activity.

The development of trispecific and tetraspecific antibodies represents the next wave of innovation in the field. These more complex molecules offer the potential to engage multiple proteins or immune cell types simultaneously, potentially leading to more precise and potent therapeutic effects. For example, researchers from the Osaka Metropolitan University and Tokyo University of Agriculture and Technology jointly developed a series of trispecific antibodies to engage T cells and NK cells simultaneously against tumors overexpressing the EGFR receptor, potentially offering a more robust anti-tumor response than bispecific antibodies.

The market opportunity for next-generation multispecific antibodies is substantial and multifaceted. There is room for expansion beyond the current 13 approved bispecific antibodies. As more complex multispecific antibodies progress through clinical trials, we can expect a surge in new approvals, each potentially addressing unmet medical needs or offering improved efficacy over existing therapies.

Moreover, the versatility of multispecific antibodies opens doors to applications beyond oncology. While cancer remains the primary focus, research is underway to apply this technology to autoimmune diseases, infectious diseases and neurological disorders. The diversification of therapeutic areas represents a vast untapped market potential. At present, Hemlibra stands at the forefront of multispecific antibodies developed for non-cancer indications, cementing its place as the highest-selling bispecific antibody in the market for several years consecutively.

The financial trajectory of the multispecific antibody market is highly promising. Having crossed the US$ 8 billion market in 2023, our analysis projects continues robust growth and the market is expected to surpass USD 40 Billion by 2029. Factors driving this growth include the increasing incidence of cancer worldwide, growing acceptance of immunotherapy approaches, and the potential for these therapies to commands premium pricing due to their complex engineering and enhanced efficacy.

In conclusion, the next generation multispecific antibody market presents a compelling opportunity for growth and innovation in the biopharmaceutical industry. With its strong foundation in bispecific antidotes and the emerging potential of tri- and tetraspecific antibodies, this field is poised for significant expansion beyond its currently US$ 8 billion market size. As research progresses and more products receive approved, multispecific antibodies are set to play an increasingly important role in the treatment of cancer and potentially other diseases, offering substantial rewards for companies at the forefront of this technological revolution.

Global Multispecific Antibodies Market, Drug Sales, Price & Clinical Trials Insight 2029 Report Highlights:

Global & Regional Market Analysis

Global Multispecific Antibodies Market Opportunity: > USD 40 Billion

Global Multispecific Antibodies Market Sales in 2023: > USD 8 Billion

Number of Approved Multispecific Antibodies: 13

Approved Antibodies Global, Regional, Annual & Quarterly Sales Insight

Approved Antibodies Dosage & Pricing Insight

Number of Multispecific Antibodies in Clinical Trials: > 900

Comprehensive Insight on All Antibodies in Clinical Trials by Company, Country, Indication, & Phase

Key Topics Covered:

1. Introduction to Next Generation Multispecific Antibodies

2. Multispecific Antibody Current Clinical Development & Future Commercialization Outlook 2.1 Current Market Overview 2.2 Future Commercialization Opportunity

3. Multispecific Antibody Proprietary Technologies by Company

4. Multispecific Antibody Clinical Development & Market Trends by Region 4.1 US 4.2 EU 4.3 China 4.4 UK 4.5 Japan 4.6 Australia 4.7 South Korea 4.8 Canada

5. Multispecific Antibody Clinical Trends by Indication 5.1 Cancer 5.2 Hematological Disorders 5.3 Microbial Infections 5.4 Autoimmune & Inflammatory Disorders 5.5 Ocular Diseases

6. Approved Multispecific Antibodies - Clinical Overview, Pricing & Dosage Insight 6.1 Overview 6.2 Clinical Overview, Pricing & Dosage Insight

7. Approved Multispecific Antibodies - Sales Insight (2020 - H1'2024)

8. Global Multispecific Antibodies Clinical Trials Overview (2024 - 2029) 8.1 By Phase 8.2 By Country/Region 8.3 By Company 8.4 By Indication 8.5 By Priority Status 8.6 Patient Segment

9. Global Bispecific Antibodies Clinical Trials by Company, Indication & Phase 9.1 Research 9.2 Preclinical 9.3 Phase-I 9.4 Phase-I/II 9.5 Phase-II 9.6 Phase-II/III 9.7 Phase-III 9.8 Preregistration

10. Marketed Bispecific Antibodies Clinical Insight by Company, Country & Indication

11. Global Trispecific Antibodies Clinical Trials Insight by Company, Country, Indication & Phase 11.1 Research 11.2 Preclinical 11.3 Phase I 11.4 Phase I/II

12. Tetraspecific Antibodies Clinical Trials Insight by Company, Country, Indication & Phase 12.1 Preclinical 12.2 Phase I 12.3 Phase I/II 12.4 Phase II

13. Competitive Landscape 13.1 AbbVie 13.2 ABL Bio 13.3 Abzyme Therapeutics 13.4 Affimed Therapeutics 13.5 Akeso Biopharma 13.6 Alligator Bioscience 13.7 Amgen 13.8 Antibody Therapeutics 13.9 APITBIO 13.10 Astellas Pharma 13.11 AstraZeneca 13.12 Aptevo Therapeutics 13.13 BioAtla 13.14 Biocytogen Pharmaceuticals 13.15 Biosion 13.16 EpimAb Biotherapeutics 13.17 FutureGen Biopharmaceutical 13.18 Genentech 13.19 Genmab 13.20 Genor Biopharma 13.21 Gensun Biopharma 13.22 Harbour BioMed 13.23 Harpoon Therapeutics 13.24 IGM Biosciences 13.25 I-MAB Biopharma 13.26 ImmuneOnco Biopharma 13.27 ImmunoPrecise Antibodies 13.28 Innate Pharma 13.29 Innovent Biologics 13.30 Invenra 13.31 Kenjockety Biotechnology 13.32 LaNova Medicines Limited 13.33 Light Chain Bioscience 13.34 Linton Pharm 13.35 Lyvgen Biopharma 13.36 MacroGenics 13.37 Merus 13.38 ModeX Therapeutics (OPKO Health) 13.39 Molecular Partners 13.40 NovaRock Biotherapeutics 13.41 Numab 13.42 OPKO Health 13.43 Pfizer 13.44 Regeneron Pharmaceuticals 13.45 Revitope 13.46 Roche 13.47 Ruijin Hospital 13.48 Sanofi 13.49 Sichuan Baili Pharmaceutical 13.50 SystImmune 13.51 Virtuoso Therapeutics 13.52 Xencor 13.53 Y-Biologics 13.54 Zhejiang Shimai Pharmaceutical 13.55 Zymeworks

For more information about this report visit https://www.researchandmarkets.com/r/7lnlu6

About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

New biomaterial regrows damaged cartilage in joints

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Northwestern University scientists have developed a new bioactive material that successfully regenerated high-quality cartilage in the knee joints of a large-animal model.

Although it looks like a rubbery goo, the material is actually a complex network of molecular components, which work together to mimic cartilage’s natural environment in the body.

In the new study, the researchers applied the material to damaged cartilage in the animals’ knee joints. Within just six months, the researchers observed evidence of enhanced repair, including the growth of new cartilage containing the natural biopolymers (collagen II and proteoglycans), which enable pain-free mechanical resilience in joints.

With more work, the researchers say the new material someday could potentially be used to prevent full knee replacement surgeries, treat degenerative diseases like osteoarthritis and repair sports-related injuries like ACL tears.

The study will be published during the week of August 5 in the Proceedings of the National Academy of Sciences.

“Cartilage is a critical component in our joints,” said Northwestern’s Samuel I. Stupp , who led the study. “When cartilage becomes damaged or breaks down over time, it can have a great impact on people’s overall health and mobility. The problem is that, in adult humans, cartilage does not have an inherent ability to heal. Our new therapy can induce repair in a tissue that does not naturally regenerate. We think our treatment could help address a serious, unmet clinical need.”

A pioneer of regenerative nanomedicine, Stupp is Board of Trustees Professor of Materials Science and Engineering, Chemistry, Medicine and Biomedical Engineering at Northwestern, where he is founding director of the Simpson Querrey Institute for BioNanotechnology and its affiliated center, the Center for Regenerative Nanomedicine . Stupp has appointments in the McCormick School of Engineering , Weinberg College of Arts and Sciences and Feinberg School of Medicine . Jacob Lewis, a former Ph.D. student in Stupp’s laboratory, is the paper’s first author.

What’s in the material?

The new study follows recently published work from the Stupp laboratory, in which the team used “dancing molecules” to activate human cartilage cells to boost the production of proteins that build the tissue matrix. Instead of using dancing molecules, the new study evaluates a hybrid biomaterial also developed in Stupp’s lab. The new biomaterial comprises two components: a bioactive peptide that binds to transforming growth factor beta-1 (TGFb-1) — an essential protein for cartilage growth and maintenance — and modified hyaluronic acid, a natural polysaccharide present in cartilage and the lubricating synovial fluid in joints.

“Many people are familiar with hyaluronic acid because it’s a popular ingredient in skincare products,” Stupp said. “It’s also naturally found in many tissues throughout the human body, including the joints and brain. We chose it because it resembles the natural polymers found in cartilage.”

Stupp’s team integrated the bioactive peptide and chemically modified hyaluronic acid particles to drive the self-organization of nanoscale fibers into bundles that mimic the natural architecture of cartilage. The goal was to create an attractive scaffold for the body’s own cells to regenerate cartilage tissue. Using bioactive signals in the nanoscale fibers, the material encourages cartilage repair by the cells, which populate the scaffold.

Clinically relevant to humans

To evaluate the material’s effectiveness in promoting cartilage growth, the researchers tested it in sheep with cartilage defects in the stifle joint, a complex joint in the hind limbs similar to the human knee. This work was carried out in the laboratory of Mark Markel in the School of Veterinary Medicine at the University of Wisconsin–Madison.

According to Stupp, testing in a sheep model was vital. Much like humans, sheep cartilage is stubborn and incredibly difficult to regenerate. Sheep stifles and human knees also have similarities in weight bearing, size and mechanical loads.

“A study on a sheep model is more predictive of how the treatment will work in humans,” Stupp said. “In other smaller animals, cartilage regeneration occurs much more readily.”

In the study, researchers injected the thick, paste-like material into cartilage defects, where it transformed into a rubbery matrix. Not only did new cartilage grow to fill the defect as the scaffold degraded, but the repaired tissue was consistently higher quality compared to the control.

A lasting solution

In the future, Stupp imagines the new material could be applied to joints during open-joint or arthroscopic surgeries. The current standard of care is microfracture surgery, during which surgeons create tiny fractures in the underlying bone to induce new cartilage growth.

“The main issue with the microfracture approach is that it often results in the formation of fibrocartilage — the same cartilage in our ears — as opposed to hyaline cartilage, which is the one we need to have functional joints,” Stupp said. “By regenerating hyaline cartilage, our approach should be more resistant to wear and tear, fixing the problem of poor mobility and joint pain for the long term while also avoiding the need for joint reconstruction with large pieces of hardware.”

The study, “A bioactive supramolecular and covalent polymer scaffold for cartilage repair in a sheep model,” was supported by the Mike and Mary Sue Shannon Family Fund for Bio-Inspired and Bioactive Materials Systems for Musculoskeletal Regeneration.

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