Clinical Delivery
Cell & Gene Therapy Trial Support
Specialist support for the logistics, safety and regulatory requirements of cell and gene therapy trials.
What's Included
- Apheresis and treatment site qualification
- Chain of identity and chain of custody management
- Courier qualification, cold-chain logistics and mock shipments
- Manufacturing slot coordination and vein-to-vein scheduling
- CRS/ICANS management training and toxicity algorithms
- Replication-competent virus (RCL/RCR) and insertional oncogenesis monitoring
- Long-term follow-up (LTFU) protocols and programs (up to 15 years)
- Lab manuals, sample management and central lab coordination
- Gene therapy regulatory requirements (FDA CBER, EMA ATMP, SFDA)
Cell and Gene Therapy
Hands-On CAR-T Experience
Our team has worked on autologous CAR-T trials, where each patient's cells go from apheresis to manufacturing and back on a tight schedule. We qualify sites and couriers, run mock shipments, protect chain of identity and custody, and set up long-term follow-up.
- 1Apheresis Site Qualification
- 2Courier Qualification and Cold Chain
- 3Manufacturing Slot Coordination
- 4Vein-to-Vein Scheduling
- 5Treatment Site and CRS/ICANS Oversight
- 615-Year Long-Term Follow-Up
CAR-T Trial Experience
Early phase to Phase II, in the United States, Europe, the Middle East (including Saudi Arabia), Turkey and Latin America.
Regulatory Experience
CAR-T regulatory work with the FDA (IND submissions, clinical hold responses) and other agencies, including IMPD and CMC dossiers.