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Clinical Research & Healthcare Regulatory Compliance

clinical research organizationBy: Jeff Cohen

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 re 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–


Though a practice may in fact have lots of patients, number of patients does not itself translate into patients eligible to enroll in a study.  In fact, the restrictions on study protocols tend to expand, which means that the number of patients screened versus those enrolled in a study can be elusive.


Healthcare regulatory compliance for Sites arises in the context of significant and serious FDA regulations.  Getting them right isn’t easy and is something of a moving target.


Running research studies isn’t cheap.  The more patients screened, the more physicians and mid level practitioners needed to screen.  And the more research coordinators necessary to hire.  These are not administrative employees with low salaries.  They’re professionals with professional salaries.  Relatedly, cost is also related to income.  Without proper experience setting and negotiating study budgets with Sponsors and CROs, practices will be on the losing side of the equation.


Running a research study is time consuming.  Though many physicians may think administering a research study and staffing it is within reach, physicians who have not thoroughly vetted the opportunity will be disappointed to learn that, even with proper staffing, research will take time away from the core income generator, the medical practice.

Medical practices need to take time to thoroughly examine the staff and financial needs of developing a line of business consisting of research studies.  They ought to also examine partnerships that make sense where partners alleviate some of the burdens above in exchange for sharing the budget based fees.