Translate Drug Content Changes to Clinical Trials

Advise Product Development Team on implementation strategy and logistics from a pharmacist end-user perspective. Promote collaboration between Product Development and Clinical Operations to implement drug content changes into clinical trials programs.

One challenge of drug development is bringing the science to the patient. After Product Development (PD) makes a recommendation (e.g., changes in drug preparation, stability, dilutions, CSTD compatibility, etc.), who determines if the change is significant enough to warrant an immediate Pharmacy Manual update or to justify a mid-study implementation, increasing the pharmacist burden and leading to disgruntled sites? This can be a conundrum to both PD and Clinical Operations (CO). From a PD perspective, rolling out a large change quickly to all studies make sense. But from a CO perspective, each clinical trial is unique, so it may not be so straightforward. For a smooth transition, ask a pharmacy subject matter expert since they uniquely understand the impact of product changes to drug delivery and end-user workflow.