Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases. There […]
Community Engagement in Clinical Trials with Chris Komelasky
August 7, 2023
The FDA wants pharmaceutical and medical device manufacturers to enroll diverse patients in clinical trials. One way to achieve the diversity goal is […]
Community Health System-based Research with JoAnne Levy
April 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 […]
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 […]
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, […]
Introduction to Coverage Analysis with Kelly Willenberg
April 30, 2022
In this episode, we tackle another important aspect of clinical research finance, specifically, coverage analysis for US based clinical trials. At the beginning […]
Clinical Data Management with Mariam Mirgoli
March 31, 2022
There is more to the world of clinical data management than building and cleaning databases. Did you know you can leverage your clinical […]
Clinical Research Billing for Small to Medium Sites with Kristi Etchberger
February 23, 2022
A big part of managing clinical research at any site is managing clinical research billing. If you don’t keep track of your research […]
Integrating EHR and EDC Systems with Hugh Levaux
January 23, 2022
One of the most time and resource intensive tasks in clinical research is data entry. Clinical research coordinators spend countless hours transferring clinical […]
Software Solutions for Clinical Research Sites with Ryan Jones
November 22, 2021
As the clinical research ecosystem becomes more site and patient centric, I was curious about what an ideal software stack looks like for […]
Diversity, Inclusion, and Equity in Clinical Research with Barbara Bierer, M.D.
August 31, 2021
Dr. Bierer is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center and […]
Patient Recruitment Failure in Clinical Trials
June 30, 2021
Top 10 Reasons for Patient Recruitment Failure in Clinical Trials This episode and post highlights the Top 10 Reasons for Patient Recruitment Failure […]
Regulatory Affairs for Medical Device Clinical Trials with Priya Jagasia
June 6, 2021
Clinical trials are conducted in compliance with regulations. Simply stated, you need a clinical and regulatory strategy when it comes to conduct of […]
Decentralized Clinical Trials with Derk Arts
May 31, 2021
The pandemic has helped fast track the adoption of technology in clinical research. This has been a much needed change and we’re headed […]
Psychedelic Clinical Trials with Rebecca Matthews
February 28, 2021
My guest for this interview is Rebecca Matthews, Chief Clinical Operations Officer at Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation. In […]
Diversity and Inclusion in Clinical Trials with Jennifer Jones-McMeans, Ph.D.
January 28, 2021
Do you want to know more about diversity in clinical trials? Are you a Sponsor looking to develop a robust clinical trial strategy? […]
Clinical Trial Readiness with Joel Selzer
December 31, 2020
One of the biggest challenges in clinical study start-up and conduct is “training.” A few factors that impact training include the clinical site […]
Clinical Research Soft Skills with Ed Hogan
November 24, 2020
Many people talk about technical skills in clinical research. You need to know Microsoft Excel. You need to understand Good Clinical Practice. You […]
Patient Support Programs in Middle East and North Africa (MENA) with Maha Dakhloul
November 8, 2020
In this episode, I had an opportunity to speak with Maha Dakhloul on the topic of Patient Support Programs (PSPs) in the Middle […]
