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Clinical Research & Healthcare Regulatory Compliance Print E-mail
Written by Jeffrey L. Cohen   
Monday, 21 August 2017 00:00

Doctors often consider the idea of clinical research to be an easy "add on" to their practices. The usual idea is "I already have the patients. This'll be easy." But that's not the case when you start to look at the healthcare regulatory compliance issues!

Pharmaceutical companies ("Sponsors") are often looking for resources for clinical research. They usually turn to clinical research organizations (CROs) to find research centers (Sites) and to manage some of the healthcare regulatory compliance issues in a way that creates enough distance between the Sponsor and the Site in hopes that the metrics from the patients enrolled in the study will provide clarity regarding the efficacy of a tested drug.

Medical practices that think it'll be easy to become a Site will be very surprised by some of the key challenges, which include...

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