Cell and Gene Therapies

Your partner in developing cell, gene and other advanced therapies

Access multi-disciplinary, multi-modality experience to support your unique studies.

Get a patient-centric approach to optimize the development of your product.

Rely on our team to navigate complex logistics and implement practical solutions.

Fortrea’s Cell and Gene Therapy team brings dedicated cell and gene expertise for emerging target indications. With our multi-disciplinary operational, medical, and regulatory experience, we can provide comprehensive, strategic insights to enable efficient, cost-effective development of your therapeutic and reduce risk across critical milestones.

By integrating critical services within a single global organization, we can amplify your clinical trial approaches, streamline complex processes and minimize risk. We are committed to helping you transform the future of healthcare by bringing promising cell and gene therapies to more patients.

Experience matters when choosing a partner.

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In the last 5 years

We’ve been honored to serve as a CRO partner of choice for our biotech and pharmaceutical customers as we’ve advanced their development.

150+

studies

1,449

Sites

15,845

Patients

Advance your cell therapy studies

At Fortrea, we’ve seen the cell therapy field evolve and have played a significant role in its development by supporting and designing dozens of cell therapy programs, including all 6 FDA-approved CAR T-cell therapies.

Learn about our cell therapy experience ›

Leverage our global gene therapy experience

No matter where you are or where you intend to go, you can rely on our global experience and expertise in advancing gene therapy trials.

Learn about our gene therapy experience ›

Focus on oncology in cell and gene therapy development

From targeted therapies and immunotherapies to advanced cell and gene therapies, our subject matter experts have helped develop biomarker-driven strategies to bring precision medicines to market.

Learn about our oncology experience in cell and gene therapies ›

Get the latest cell and gene therapy updates.

We're sharing our latest news, events, and publications.

Webinar

Exploring Applications of CAR-T Therapy Outside Oncology: Strategies for Applying Lessons Learned (60 min)

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White Paper

De-risking the patient journey in cell therapies: six key considerations

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Article

Advancing cell and gene therapy frontiers

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Info Sheet

Clinical development solutions for cell and gene therapy

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White Paper

Examining the role of genetic counselors to promote patient centricity in cell and gene therapy clinical trials

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White Paper

Combined advanced therapy medicinal products: European regulatory requirements, pathways and processes

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We’re here to seamlessly deliver your next cell or gene therapy trial.

Working as an extension of your team, we can offer you:

Experience with multiple modalities
CAR-T and AAV

Other viral and non-viral delivery systems (e.g., adenovirus, LNP)

Cell therapies (immune cell/stem cell, autologous/allogeneic, modified/non-modified)

Gene editing (e.g., CRISPR, meganucleases)

Advanced and complex therapeutics such as RNA-based therapies (e.g., ASOs, siRNAs), T-cell engagers and genetically modified organisms
Scientific and medical expertise
Not only do we know how to work with these complex entities and recognize real or potential impacts on patient well-being, but we also understand the science behind how they work. We understand how these treatments are developed and manufactured, and how these complex characteristics impact the conduct of a clinical trial including:

Protocol development

Long-term follow-up (LTFU)

Development of companion diagnostics

Global regulatory requirements

Vendor qualification

Medical monitoring
Global operational solutions
The complexity of these therapies can involve numerous operational challenges defined by the asset in development and reflected in the trial footprint. We offer best practices, solutions and technologies and operational flexibility to optimize the conduct of your clinical trial, including, but not limited to:

Providing logistics support for autologous CAR-T cell therapies

Navigating site selection, activation, and overall study setup

Defining regulatory and GMO pathways timelines along with approvals

Reducing the patient burden for LTFU studies

Designing and implementing a program’s regulatory strategy, including early engagement (e.g., INTERACT, pre-IND), and when working with rare diseases and pediatrics
Customized training

To ensure your team keeps up with complex and rapidly evolving technologies, we provide comprehensive custom training of all team members. Our Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT) and Oncology members provide targeted, study-specific training, as well as a formal Cell and Gene Therapy Training curriculum.

Serving as your agile partner for complex and novel clinical trials

Let our multidisciplinary experts put their insights and experience to work to advance your program. Together, we’ll improve your potential for success and make a difference in urgent unmet medical needs.

Explore our related areas of expertise.

Rare Diseases Pediatrics Oncology Our Team (RAPT)

Your needs. Our solutions.

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 to drive healthcare innovation throughout the world.