Collaborative sponsor-contract research organization (CRO) relationships can be the key to ensuring outsourced clinical trial activities run smoothly. One area where strong partnerships are of paramount importance is the Trial Master File (TMF). While regulatory responsibility for oversight lies with the trial sponsor to demonstrate GCP (Good Clinical Practice) during a clinical study, CROs play a critical part when they assume a role in the conduct of the study.
In a February 2023 FierceBiotech webinar, “Improving Sponsor Oversight of the Trial Master File at Chiesi: A Case Study,” pharmaceutical company Chiesi and CRO CROMSOURCE shared best practices from their decades-long partnership integral to ensuring inspection-ready TMFs. This is a brief summary of their findings.