ATMP clinical development
Advanced therapy medicinal products
Advanced therapy medicinal products (ATMPs) are cutting-edge biologics pioneering a relatively new field of precision medicine. Whether your ATMP is based on gene therapy, cell therapy or tissue engineering, we want to help you drive your biologic through clinical development so patients can benefit from these new technologies.
ATMP risk-based approach
Clinical development of ATMPs is relatively new and existing guidelines have recently been revised. The ATMP-specific Good Manufacturing Practice (GMP) guideline focuses on a risk-based approach, and this way of thinking is crucial in this novel and complex field where there is a perpetual interplay between known and unknown risk factors.
Flexible solutions responsive to your needs
SCRO understands the importance of the risk-based approach and asking the right questions at the right time. We offer custom and flexible solutions based on your needs, whether it includes standalone services or designing an entire clinical study or program for your ATMP.
