# #338: Site Selection for Clinical Trials

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-10-06
- Length: 54m
- Episode: 338
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-06-338-site-selection-for-clinical-trials
- Listen: https://podcast.greenlight.guru/episode/338-site-selection-for-clinical-trials

## Summary

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.

## Outline

1. Introduction and Guest Backgrounds
2. The Protocol as the Foundation for Site Selection
3. Feasibility Questionnaires and Site Qualification Visits
4. Patient Diversity and Demographic Planning
5. Global Site Selection and IRB Strategies
6. Timeline Impacts and KOL Management
7. Technology Tools and Final Advice

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

early-stage companies

## Mentioned

- Proxima Clinical Research (company)
- Greenlight Guru (company)
- FDA (other)
- IRB (other)
- IDE (other)

## Related episodes from other shows

- [038 - "Clinical Trials" with Dan Sfera](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera) (Let's Combinate)
- [Combi Crumbs: Clinical Trials 101 – From Safety to Strategy](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-12-combi-crumbs-clinical-trials-101-from-safety-to-strategy) (Let's Combinate)
- [084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-10-084-drug-discovery-candidate-selection-pre-clinical-development-ind-submissions) (Let's Combinate)
- [176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski](https://hardwarepodcasts.com/podcast/lets-combinate/2025-02-19-176-the-fastest-way-to-ruin-drug-device-development-and-how-to-avoid-it-with-eri) (Let's Combinate)
- [195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-02-195-clinical-trial-design-oncology-innovation-decentralized-trials-with-archana) (Let's Combinate)

## Citing this page

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