Ultimate Guide to Managing Biological Samples for Sponsors
As a sponsor, you face numerous obligations when executing clinical trials, with the primary goal of gathering sufficient data to demonstrate the safety and efficacy of investigational products or devices. The data you collect must be defensible and complete, and biological samples represent a critical source of that data. Therefore, to successfully execute a clinical trial, the sample management process also needs to be defensible and complete. It is crucial to have visibility into the entire sample journey, as it demonstrates protocol compliance and sample traceability. Lost or mishandled samples can significantly impact research sites, patients, data integrity, and study timelines.