Hardware Podcasts

#338: Site Selection for Clinical Trials

Global Medical Device Podcast · 6 Oct 2023 · 54m · Episode 338

What this episode covers

Isabella Schmidt and Samantha Pickett from Proxima Clinical Research discuss the critical process of selecting clinical trial sites for medical devices. They emphasize starting with a complete protocol to guide feasibility questionnaires and site qualification visits, highlighting the importance of patient diversity, investigator bandwidth, and technological readiness. The experts warn against defaulting to Key Opinion Leaders (KOLs) without verifying their capacity and advise using central IRBs to accelerate startup timelines while ensuring diverse patient enrollment.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Proxima Clinical Research, Greenlight Guru
Also
FDA, IRB, IDE

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