Therapeutic Areas
All Indications, US and Global
From feasibility through Phase I–IV, in the US and globally.
Tell us your indication and we will explain how we would support the study.
Discuss Your IndicationCell 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.
Vein-to-Vein Steps We Coordinate
- 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:
- United States
- Europe
- Middle East (including Saudi Arabia)
- Turkey
- Latin America
Regulatory Experience
CAR-T regulatory work with the FDA (IND submissions, clinical hold responses) and other agencies, including IMPD and CMC dossiers.
Gene therapy regulatory requirements: FDA CBER, EMA ATMP and SFDA.
Cell and Gene Therapy Services
- 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)
Let’s Advance Your Clinical Development Program
Planning a new trial, expanding an ongoing study or looking for specialized support? Talk to our leadership team about your goals.