# Addressing Clinical Trial Challenges & Concerns during COVID-19

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-07-29
- Length: 38m
- Episode: 157
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19
- Listen: https://podcast.greenlight.guru/episode/addressing-clinical-trial-challenges-concerns-during-covid-19

## Summary

Jon Speer, founder of Greenlight Guru, interviews Isabella Schmitt and Stephanie Mole from Proxima Clinical Research about navigating clinical trials during the COVID-19 pandemic. They discuss the suspension of elective procedures, the shift to remote monitoring and electronic data capture (EDC), and the critical importance of subject safety and protocol amendments. The conversation highlights how companies from non-regulated industries can adapt to medical device regulatory requirements and the long-term industry shift toward digital workflows.

## Chapters

- [0:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19#t=42) Introduction and Pandemic Impact on Sites
- [3:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19#t=183) Elective Procedures and Global Trial Status
- [6:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19#t=360) Subject Safety and Staff Availability Risks
- [9:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19#t=556) Protocol Deviations, Amendments, and FDA Reporting
- [14:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19#t=841) Electronic Data Capture and Remote Monitoring
- [18:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19#t=1090) Virtual Visits, Telehealth, and In-Home Devices
- [21:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19#t=1262) Human Factors and Device Design Pivots
- [24:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19#t=1484) Advice for New Entrants and Site Feasibility
- [30:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19#t=1840) Future of Clinical Trials and Digital Shift

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

large enterprises

## Mentioned

- Greenlight Guru (company)
- Proxima Clinical Research (company)
- FDA (other)
- NIH (other)
- Teladoc (product)
- EDC (tool)

## Related episodes from other shows

- [Using IoT to Distribute COVID-19 Vaccines  | Luma Health's Aditya Bansod](https://hardwarepodcasts.com/podcast/iot-for-all-podcast/2021-04-26-using-iot-to-distribute-covid-19-vaccines-luma-healths-aditya-bansod) (IoT For All Podcast)
- [Ep. 15 | The Emergence of the Virtual Supply Chain in a COVID-19 World](https://hardwarepodcasts.com/podcast/moores-lobby/2020-12-17-ep-15-the-emergence-of-the-virtual-supply-chain-in-a-covid-19-world) (Moore's Lobby)
- [Mark Wehde | Engineering at The Mayo Clinic](https://hardwarepodcasts.com/podcast/being-an-engineer/2022-09-02-mark-wehde-engineering-at-the-mayo-clinic) (Being an Engineer)
- [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)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.