Managing Drug And Data Requirements In Decentralized Clinical Trials

By Henk Dieteren, Clinical Supply Chain Solutions Consultant

In decentralized clinical trials (DCTs), the successful management of investigational products (IPs) and patient data hinges on understanding the distinct regulatory requirements of the FDA and the EMA. While the FDA focuses on the characteristics of the product itself—such as its safety profile and administration—to determine suitability for home delivery, the EMA provides detailed procedural specifications for IP management. This includes verifying storage conditions at the participant's home and ensuring the IP is received by an authorized individual.

When it comes to data, the FDA emphasizes comprehensive data management plans and risk-based monitoring, while the EMA prioritizes data flow visibility, access controls, and compliance with GDPR, which adds complexity to trials with EU citizen participation. To navigate these differences, sponsors running global trials are advised to design their protocols to meet the more stringent EMA standards from the beginning, creating a unified and compliant system that reduces operational complexity.