Determining the best global supply strategy based upon the study design can be a complex discussion involving a number of variables depending upon the study design.
As global regulations change, an in-country depot solution versus direct to site shipments from a CMO can greatly impact the success and budget of a trial.
Strategy considerations:
- Depot oversight including audit requirements (Global Quality Management Systems)
- Import licence type/requirements and associated timelines
- Order strategy (including IRT look ahead period / patient dosing)
- Depot capabilities (S&D, JIT labelling, Returns and Destruction)
- Stability of product being shipped
- In country infrastructure
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