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Think clinical trial compliance is just a part-time job or a paperwork exercise that can be passed off to a medical assistant? Think again. In this episode of the KF Deep Dive, host Daran Carney sits down with Tom Sepka, CEO of HCI Healthcare Consultants and veteran Chief Pharmacy Officer, to shatter the myth that research pharmacy oversight is optional.
Together, they break down the deep operational complexities of managing investigational drugs—from navigating strict DEA registrations and state licensures to enforcing rigorous recordkeeping, environmental controls, and USP compounding regulations. Tom shares first-hand insights on how failing to build a dedicated pharmacy infrastructure directly threatens a trial's integrity, invites regulatory scrutiny, and increases liability for principal investigators. Whether you are running a large academic medical center or a scaling community research site, this conversation reveals the exact guardrails needed to keep your protocols tight, your data compliant, and your proprietary assets legally sound.
What You'll Learn in This Episode:
- FTE Realities: How to determine the exact pharmacy staffing requirements (from 1 to multiple FTEs) based on the size and scope of your clinical trials.The Pitfalls of Delegation: Why leaving investigational drug inventory, blinding, and randomization to non-pharmacy staff is an immense regulatory gamble.Complex Controls: Navigating the layers of state boards, the FDA, USP 797, and the DEA—especially in emerging research spaces like psychedelics and cannabis.End-of-Life Protocols: The standard practices for handling drug disposal and reverse distribution when sponsors go dark or trials close.
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