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Community health system clinical trials with JoAnne Levy at Mercy Research

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 […]

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Postmarket Surveillance Studies with David Rutledge

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 […]

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Patient Reported Outcomes (PRO) design

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 […]

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How to Plan Investigator and Steering Committee Meetings

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 […]

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Clinical Trial Outsourcing with Anca Copaescu

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 […]

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Early Phase Clinical Research

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 […]

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Patient Recruitment in Early Phase I Trials

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 […]

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Liz Dalton Medical Imaging in Clinical Trials

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 […]

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clinical research data transparency darshan kulkarni

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 […]

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Getting NIH funding and launch a clinical trial with Dr. Manish Shah

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, […]

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