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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.

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. 


Advanced therapy studies





Watch our cell and gene therapy webinar  

In this 61-minute, on-demand presentation, our speakers discussed recent progress in several therapeutic areas, provided updates in kidney disease and shared operational considerations when planning cell and gene therapy clinical development programs as well as conducting pediatric gene editing studies. 

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


  • 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:

    • プロトコルの開発
    • 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. 当社とともに、お客様の可能性を成功へと導き、まだ満たされていない差し迫った医療ニーズに一石を投じましょう。

Explore our related areas of expertise. 


希少疾患 小児科 オンコロジー Our Team (RAPT)

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