Episode 93 | Danielle Bodicoat | The Scientific Art of Biostats: Clinical Strategy, Sample Size Calculation, Clinical Trial Design, and CEP/CERs

Project Medtech

English - May 16, 2022 05:00 - 35 minutes - 49.4 MB
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Previous Episode: Episode 92 | Nick Accordino and Will Braeutigam: Deloitte | Taking your Medtech Company Public: SPACs vs. IPOs

Next Episode: Episode 94 | Mary Yost, Co-Founder at the Sage Group | Peripheral Arterial Disease (PAD): Undiagnosed and Under-treated --- A Dive into the Financial Burden on the Healthcare System

In this episode, Danielle Bodicoat and Duane Mancini discuss being a biostatistician (medical statistics), why she started her own consulting practice, the importance of clinical evidence beyond regulatory requirements, the cost drivers of a clinical trial, factors that go into clinical trial design, the basics of sample size calculation, clinical evaluation plans and clinical evaluation reports, the MDR and how it is affecting clinical in the EU and UK, and so much more.
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