Episode 318

The Tools that Make Clinical Investigations

What makes a clinical investigation run smoothly?


In today’s conversation, you’ll hear from Jon Bergsteinsson as we speak about electronic data capture for clinical investigations.


Jon has a master’s degree in biomedical engineering and is the founder of SMART-TRIAL by Greenlight Guru, which helps MedTech companies close the gap between their devices and clinical data. He was the CTO of SMART-TRIAL from 2013 to 2017, and since then has been leading SMART-TRIAL’s clinical operations. His valuable insights come from 10 years of experience in the MedTech clinical space plus a strong technical background.

Listen to today’s episode to hear what Jon has to say about using Electronic Data Capture (EDC) systems in clinical investigations, the importance of data quality and what that really means, the tools available for clinical investigations, and educating leadership about clinical investigations.

Some of the highlights of this episode include:

  • The biggest challenges companies face during clinical investigations
  • What kinds of tools are available for clinical Investigations
  • The relationship between data quality and formatting
  • The impact a purpose-built tool has on a company
  • The costs associated with clinical investigations
  • Educating leadership about clinical operations
  • What makes the best stand out

Memorable quotes from Jón I. Bergsteinsson:

“Data quality has everything to do with how you format your data.”

“The leadership just doesn’t have that much of an understanding of what clinical operations do, so they need to be educated.”

“When you have a person who’s very efficient, you can get 100 attributes in a couple of minutes.”

“Digital first is what sets the best from the rest.”

Links:

Jón Bergsteinsson

SMART-TRIAL by Greenlight Guru

Etienne Nichols LinkedIn

Greenlight Guru Academy

Greenlight Guru


About the Podcast

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Global Medical Device Podcast powered by Greenlight Guru
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts ...

About your host

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Etienne Nichols

Mechanical Engineer, Medical Device Guru, and host of the Global Medical Device Podcast