Reconciling Your Supply, Managing Your Returns

While planning for clinical returns often takes a backseat to preparing for First Patient In, it shouldn’t be an afterthought. Having a strategy in place from the start of your clinical trial will ensure compliance and efficiency in processing unused investigational medicine. This is important not only for a smooth study closeout, but because returns may happen mid-trial, too. As your clinical supply partner, we’ll help you navigate regulatory requirements, coordinate return and disposal logistics, and prepare documentation so your clinical trial may be closed without unexpected complications or fees.

Xerimis can process your returns and provide accountability reporting to the level you specify. For example, one trial may need simple verification of a returned shipper; another may need reconciliation down to individual dosage counts. We follow strict processes to ensure your drug inventory is accurately reconciled, documented, and reported.

Enlist Xerimis’ Expertise for Any of the Following:

• Development of detailed plan for processing your clinical returns
• Coordination of returns from clinical sites or from patients
• Reconciliation to any level requested, from shippers to dosage counts
• Accountability documentation for regulatory compliance 
• Oversight of international returns and accountability via Xerimis’ partner-depots
• IRT interaction, including recalls and recovery tracing
• For-cause inspection of returned products, used and unused
• Storage and monitoring of returns for potential use as pooled supply or eventual destruction
• Certified destruction of hazardous and non-hazardous materials through qualified vendors
• Processes aligned with FDA, EMA and MHRA expectations for accountability and destruction