[Ed Groleau]

Reply To: Clinical Supply Return Reconciliation

It sounds like you are debating responsibilities between the Clin Ops and Clin Supplies. This has been a great debate within the industry since drug development started. Returns are not glamorous and both groups point at the other but in reality both functions need to be involved. It isn’t straightforward. There is no clear line differentiating what each function must do so every company needs to establish a process per trial. Clin Ops should handle aspects that are required at the sites and Supply covers the depots but it blurs between them. For instance, who maintains the COD files, especially if there is a mix with some destructions at sites and some at the warehouse? Since Agencies will hold the sponsors ultimately accountable they need to work with all vendors used by both Clin Ops and Supply to work out a robust process. Tools like RACIs and Process Flows are essential and including returns in the IRT capabilities is extremely helpful. Many vendors offer services that will help but both functions need to work together to decide on the responsibilities. A cage death-match also works.