Chimeric Antigen Receptor (CAR) T-cell therapies represent one of the most advanced, complex, and
personalized treatment frontiers in modern medicine. Conducting clinical trials in this space requires not
only technical excellence, but also unmatched operational agility, regulatory expertise, and a deep
understanding of cellular therapy ecosystems.
Raptim is uniquely positioned to meet these demands and support the successful execution of CAR T-cell clinical research.
1. Proven Track Record in Complex Clinical Trials
- Raptim has led early- and late-phase trials across therapeutic areas, including oncology,
hematology, and immunology, which are critical foundations for CAR T research. - Our experience in rare disease models and biologics equips us with the precision needed for high
stakes, small-population studies like CAR T.
2. Advanced Regulatory Expertise
- Raptim has deep experience navigating global regulatory frameworks, including CDSCO, EMA, and
FDA requirements. - Our in-house regulatory team supports clients with accelerated pathways, IND/CTA filing, and
compliance with ATMP guidelines (Advanced Therapy Medicinal Products).
3. Specialized Site & Investigator Network
- We maintain strong relationships with transplant centers, academic hospitals, and oncology
institutes across India and key international regions. - Our feasibility team can rapidly identify CAR T-experienced PIs, GMP-capable sites, and hospital
pharmacies equipped for cryogenic handling and infusion.
4. Integrated Cold Chain & Logistics Management
- Raptim partners with qualified cold chain vendors for cryopreserved sample transport, leukapheresis coordination, and just-in-time CAR T-cell infusion logistics.
- We ensure 24/7 monitoring of temperature-controlled shipments, with full audit trail and chain-of
custody documentation.
5. Full-Service Capabilities from Bench to Bedside
- We offer end-to-end support, including:
a. Protocol design and medical writing
b. Site identification and qualification
c. Project management and pharmacovigilance
d. Data management, EDC, biostatistics, and ePRO - Our model is designed to reduce turnaround time, lower cost, and increase trial efficiency.
6. Patient-Centric and Risk-Managed Approach
- Our team is trained to manage CRS (cytokine release syndrome), neurotoxicity, and other CAR T
specific adverse events. - We proactively establish DSMB boards, medical monitoring, and early signal detection frameworks.
7. Global Outlook with Local Advantage
- With operations and partner sites across India, LATAM, Southeast Asia, and the Middle East, Raptim
provides global reach with cost-effective operations. - India’s growing CAR T research landscape and government incentives give Raptim a strategic edge
for clients aiming to expand in emerging markets.
8. Flexible Engagement and Customization
- We understand that no two CAR T trials are the same.
- Whether it’s autologous or allogeneic, academic or industry-sponsored, we offer tailored solutions
with clear communication, flexibility, and scientific partnership.
Summary: Why Raptim is the Right Choice
| Strength | Benefit |
| Expertise in complex biologic and oncology trials | Confidence in managing CAR T complexities |
| Strong regulatory knowledge | Smooth and compliant submissions |
| Specialized site and PI network | Faster enrollment and site readiness |
| Cold chain & logistics capabilities | Safe and timely cell transport |
| End-to-end service model | Single-point accountability |
| Cost-effective delivery | High quality at competitive pricing |
| Focus on patient safety & data integrity | Reliable trial outcomes |
Partner with Raptim for Your Next CAR T-Cell Study
At Raptim, we don’t just execute studies, we enable innovation. With a proactive mindset, deep therapeutic understanding, and operational rigor, we are ready to help bring your CAR T therapy from concept to clinic with confidence and speed.
Written by: Raj Kumar, Business Analyst
Email: raj.kumar@raptimreserch.com
