By Kathleen Greenough, Director of Client Solutions and Laura Araujo, Vice President of Quality, 4G Clinical
When implementing a randomization and trial supply management (RTSM) system for a clinical trial, there is a shared responsibility between the RTSM vendor and sponsor organizations to ensure the system performs as intended according to predefined requirements. The vendor is responsible for ensuring the system is properly validated to perform to requirements prior to the client accepting the system for use. According to guidance documents, regulations and industry best practices, the sponsor is responsible for supplier oversight, validation of the system in their environment (i.e. fitness for use) and to plan for risk and mitigation. This whitepaper outlines a proposed strategy for sponsors to follow that demonstrates joint responsibility for ensuring overall RTSM validation, without duplicating the efforts already taken by their vendor and ensuring proper oversight by the sponsor company.