A clinical distribution plan must be solid enough to begin planning activities, and flexible enough to adapt to inevitable changes. A good distribution plan starts with a clear idea of what countries the trial will be held in so that decisions can be made regarding the sourcing of the product, country label requirements, whether a depot is required, and QP considerations as needed.
In adapting a distribution plan to real-time changes, clinical supply managers must have mitigation strategies, a good foundation on how to adapt IRTs as necessary, and whether drugs can be returned for reuse.
Neil Fox, PCI’s Senior Clinical Supply Manager, also discusses:
- How to choose between central or decentralized sourcing
- Practices in grouping countries for label requirements
- Having well-defined processes in place to move inventory between sites, from depot to depot, or between countries (where possible) – and why it is never justified to move drugs purely for cost reasons