​Optimizing kit design to provide patients with the drug supply that they need based on protocol design while maintaining inventory flexibility across multiple sites

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Label design recommendations based on my extensive experience for both US and Global trials

 

Randomization set up guidance for both patient randomization schedules and clinical supply kits list, paying close attention to ensure that multiple trials running simultaneously have distinct ranges and that all protocol requirements are met

 

Supporting the Request for Proposal process with clinical supply vendors to help provide a comprehensive outline of services needed, ensuring quotes are easily comparable across vendors and preventing unexpected costs mid-study

 

Clinical Trial Management support including forecasting, expiration date checks and maintaining appropriate inventory levels across all depots and accounting for shipping and customs timelines for more challenging depot locations.

 

Primary packaging support focusing on identifying the best materials (film/foil/bottles/closures, etc.) to adequately provide the stability needed for the product.

 

Blister card design to provide patients with clear dosing layouts and directions to promote compliance while minimizing the size of the package

 

Cold chain considerations including packaging materials for study kits and shipper options

 

Distribution and returns protocol review including shipping systems, documentation requirements and IVR interactions.

 

Global study support including depot considerations and booklet label design