Cell & Gene Therapies

Subject matter experts in cell and gene therapies across clinical development, regulatory and commercialization disciplines.

Dedicated experts in rare diseases, pediatrics, oncology and cellular immunotherapy.

Patient-centric approaches to optimize your registration trials and long-term follow-up studies.

Cell and gene therapies are bringing new options to patients while revolutionizing the future of medicine. As you drive this innovation, Fortrea is here to provide the global infrastructure you need combined with the personalized experience you deserve.

Cell Therapies

Fortrea experts in development of cell therapies to treat cancers and other diseases have deep knowledge in a range of scientific approaches, including allogeneic or autologous products, adoptive cell therapies (such as CAR-T, NK or DC) or stem cell-derived products.

Gene Therapies

Whether you’re developing a viral vector-based therapy, such as an adeno-associated virus (AAV) or lentivirus (lenti) product or applying gene editing technologies such as CRISPR/cas9, Fortrea has the talent and expertise to help you move your products forward.

Solutions as Unique as Your Patients

Every cell therapy and gene therapy program has different medical, operational and regulatory challenges. Our expert teams have a proven track-record in both product types that can support you at every step of your development journey to:

  • Provide consultative insights to refine your strategies, study designs and execution
  • Apply best practices for early and later-stage clinical strategy, operations and logistics
  • Deploy patient-centric approaches to improve study recruitment, incorporate the voice of the patient and apply cutting-edge decentralized clinical trial solutions
  • Support regulatory submissions, agency meetings and interactions
  • Conduct long-term follow-up studies, Phase IV trials, and fulfill post-marketing commitments
  • Seamlessly coordinate and identify efficiencies across the multiple disciplines needed to achieve your objectives
  • Leverage trouble-shooting and problem-solving know-how for more rapid issue resolution in your program
By the numbers.

Supported development of 4 FDA-approved gene replacement therapies


Helped advance 2 years of delivering development solutions for advanced therapies


110+ clinical studies conducted for cell and gene therapy products in the last 5 years


20+ years of delivering development solutions for advanced therapies

Clinical Development Solutions

  • Patient identification & recruitment
  • Protocol modeling & development
  • Project & logistics management
  • Medical monitoring and specialized training for AEs
  • First-in-human/dose range-finding & escalation studies
  • Proof of Mechanism/Proof of Concept (PoM/PoC) trials
  • Regulatory & strategic product development consulting
  • Long-term follow-up preparation and testing strategies

Post-Approval Programs

  • Phase IV and real-world evidence studies
  • Product safety and pharmacovigilance
  • Long-term follow-up studies (up to 15 years)
  • Differentiation studies
  • Combination studies
  • Disease and product registries
  • Health economics
  • Field reimbursement
  • Clinical education
  • Payer and customer relations

With a breadth of scientific, operational and regulatory experience, our team can help you navigate the complexities of this rapidly evolving field. Our experience and dedication support the unique and complex nature of your cell and gene therapy programs—helping even more patients get the essential treatments they need.

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