Handling of returns and reconciliation are often a time consuming task for the involved parties. In Nomeco CTSM we have designed a special concept for handling returns where the workload on CRAs and site personnel is minimised. Full traceability and secure accountability are obtained.
We produce and provide the required materials for site handling, transport, storage and documented destruction. This includes SOP's and instructions for site personnel. Every step can be adjusted to meet specific sponsor demands.
Returned materials can be sent to destruction right after receipt or it can be stored at Nomeco CTSM until destruction green light is provided by sponsor i.e. at the end of a study. A special warehouse area is dedicated to storage of returned clinical trial materials.
Destruction of both regular clinical trial materials and controlled drugs will be fully documented and handled in compliance with the regulatory demands.