Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on […]
Postmarket Surveillance Studies with David Rutledge
April 23, 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 […]
Human-Centered Design Role in Clinical Trials with Bruce Hellman and Ben James
March 31, 2023
In this episode, we will explore the role of design in clinical trials, with a focus on electronic Patient Reported Outcome (ePROs). Most […]
Clinical Trial Site Networks with Christian Burns
January 17, 2023
In this episode, you’ll learn about the world of Clinical Trial Site Networks. There are advantages and disadvantages when it comes to being […]
Heart Failure Clinical Trials with Sonna Patel-Raman
December 29, 2022
In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices. Our guest today is Sonna Patel-Raman. […]
Medical Imaging for Clinical Trial Sites with Kelie Luby
December 10, 2022
To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials […]
Risk Management for Clinical Investigators with Bijan Elahi
November 23, 2022
Our guest today is Bijan Elahi, where we talk about risk management for clinical investigators conducting medical device clinical trials. In this episode, […]
5 Strategies for Investigator and Steering Committee Meetings with Kunal Sampat
November 14, 2022
In this episode, I’m excited to share with you 5 Strategies for planning and conducting investigator and steering committee meetings. Now that the […]
Clinical Trial Outsourcing with Anca Copaescu
September 30, 2022
If you’re a sponsor responsible for outsourcing your clinical trials or someone who is curious about what clinical trial outsourcing entails, you’re in […]
Complexity in Early Phase Clinical Trials with Dr. Oren Cohen
September 25, 2022
When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or […]