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.