Our experience supporting oncology patients in cell and gene therapy trials
Oncology Cell and Gene Therapies
Advancing revolutionary treatments for cancer
4 923
Patients screened
1 906
Apheresed patients in autologous studies
3 328
Patients dosed
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:
- Développement de protocoles
- Apheresis
- Site training
- Complex cell therapy logistics
- Long-term follow-up (LTFU)
- Development of companion diagnostics
- Global regulatory requirements for GMO and ATMP products
- Safety risk management
- Vendor qualification
- Medical monitoring
- Patient burden
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
- Training sites in managing acute infusion phase for management of cytokine release syndrome, neurotoxicity or graft versus host disease
- Reducing the patient burden including 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
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. Ensemble, nous œuvrerons à votre succès et mettrons au point un projet unique dans la mise au point de traitements médicaux non disponibles.
Explore our related areas of expertise.
Vos besoins. Nos solutions.
En tant que prestataire de services complets d'essais cliniques de phase I à IV, de pharmacologie clinique, de solutions d'accès aux soins pour les patients et autres services de support, Fortrea s'associe aux entreprises biopharmaceutiques, aux entreprises du secteur des équipements médicaux et à celles du diagnostic, qu'elles soient de grands groupes ou des entreprises de petite et moyenne taille, afin de promouvoir l'innovation dans le domaine des soins de santé dans le monde entier.