Nov 5, 2023
Providing patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike.
To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison Bateman-House, PhD, MPH, MA, an Assistant Professor...
Aug 24, 2023
Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases.
There are no certification or degree requirements to work as a clinical research professional either.
To explore the topic of clinical research as a profession, I...
Aug 7, 2023
To learn about community engagement in clinical trials, what it means, recent regulations and guidance documents, I invited Chris Komelasky, CEO and Co-founder of SiteBridge Research, on the podcast.
SiteBridge Research is an Integrated Research Organization (IRO). Chris and his team help connect physicians and their...
Apr 30, 2023
Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials.
Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth.
Mercy Research is one of...
Apr 24, 2023
In this episode, we’re going to talk about Postmarket Surveillance Studies.
In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies.
The importance of...