Returns, Accountability & Destruction
Guaranteed compliance through key final stages of clinical development
At Xerimis, we know the requirements for every trial are different. For one trial, you may need surplus destruction capabilities. For others, you may need verifications of returns and inventory reports (detailing dosage form count, shipping /usage ratios, and product reconciliation). Meeting the inventory requirements of your project is our primary aim. Only when satisfied will the project be complete.
We help our clients navigate regulatory requirements ensuring accuracy, compliance and proper documentation. We prepare receipts of returns, accountability reports, and destruction verification reports according to your specification.
The processes we’ve implemented avoid trial outcome complications and prevent violation fees. Enlist Xerimis’ expertise for any of the following:
- Protocol-specific accountability and reporting, including all necessary clerical documentation
- Oversight of returns and accountability for international sites/depots
- Third-party destruction with certificates of destruction
- Management and witnessing of destruction for controlled drug substances
At Xerimis, we coordinate the receipt of product from clinical sites and perform customized accountability to whatever level of detail is determined by the client. This may mean a simple verification of receipt of a return from a site, or a physical inventory of the return including a dosage form count. We prepare complete accountability reports in customized formats, detailing the quantities shipped versus quantities used.