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.
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.
Experience matters when choosing a partner.
156
Advanced therapy studies
1,665
Sites
17,082
Patients
Our top therapeutic areas for cell and gene therapies include:
Get the latest cell and gene therapy updates.
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On-Demand Webinar
Updates in Cell and Gene Therapy: Current Trends and Operational Considerations (61 Minutes)
White Paper
Fortrea's cell and gene therapy operational solution
White Paper
De-risking the patient journey in cell therapies: six key considerations
Article
Advancing cell and gene therapy frontiers
Info Sheet
Clinical development solutions for cell and gene therapy.
We’re here to seamlessly deliver your next cell or gene therapy trial.
Working as an extension of your team, we can offer you:
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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
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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
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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
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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.
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.
