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 […]
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 […]
Patient Recruitment in Phase I Studies with Dr. Graham Wood 
August 31, 2022
Phase I trials (also known as early phase trials) involve healthy participants or participants with no treatment options, such as cancer patients. Unlike late phase trials (Phase […]
Medical Imaging in Clinical Trials with Elizabeth Dalton
July 31, 2022
In this episode, I’m excited to talk about medical imaging in clinical trials. We’ll discuss the role of a medical imaging CRO, imaging […]
Clinical Research Data Transparency with Darshan Kulkarni
July 31, 2022
Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have […]
Launching an NIH Funded Study with Dr. Manish Shah
July 20, 2022
In the fiscal year 2021, the National Institute of Health (NIH) funded only 16,959 out of 80,878 research project grants. In other words, […]
