In order to provide a comprehensive end to end clinical trial supply solution, our holistic approach encompasses seamless returns management and approved destruction services, supporting the unique demands of clinical trials with transparency and regulatory compliance.
Return of unused IMP
All too often, the requirement for return of unused IMP from clinical sites is not considered during the initial planning stage, meaning that storage of supplies can become an issue for sites when the process is set up part way through a study. This aspect of study management should be identified in the set up phase as this process can be complex, involving multiple depots if local distribution centres are being utilised.
PNR Pharma takes a proactive approach in managing drug returns and disposal. We can receive and store returned medication at the appropriate conditions throughout a study until the reconciliation is complete and the Sponsor issues approval for its destruction.
PNR Pharma has an established process for product reconciliation, at a level to meet the requirements of the study. Accountability for a product prescribed and administered to a patient will be the responsibility of clinical site staff. However, PNR Pharma can perform additional checks on the product returned, if required . This is agreed between both parties by means of a study specific Returns Specification.
PNR Pharma offers a destruction service that manages the disposal of clinical drug products throughout the clinical study, which includes approval from the study Sponsor. This can be handled at our own facilities or in collaboration with our Global Depot partners.
Products are inventoried, securely packed and collected by an approved incineration supplier for final disposal, with a Certificate of Destruction provided.
We invite you to partner with us on your pharmaceutical journey, where our goal is to facilitate EU and UK access to clinical and commercial medicines. If you’re looking for services that uphold industry standards and regulatory compliance, PNR are here to assist you. Contact us today to learn more about our offerings and how we can support your needs.