Blog

As Christina Brennan, MD, MBA, CCRC, FACRP, begins her volunteer duties as the 2025 Chair of the ACRP Board of Trustees, she took time to answer some questions about her experience in the clinical research enterprise, some of the challenges and opportunities facing it, and how ACRP can be of service to its members and stakeholders.

While the U.S. Department of Justice continues to prioritize its investigation of fraud and misconduct within the clinical research space, the Office of Research Integrity (ORI)-Department of Health and Human Services (HHS) recently released its Final Rule on regulations governing Public Health Service Policies on Research Misconduct, which takes effect January 1, 2025. Clearly, the role of compliance in clinical research is a critical area of focus, one with the potential for significant consequences if overlooked or minimized.  

Whether it is a case of early-career love at first sight or an arena that a seasoned job seeker enters for a change of pace after time spent in traditional drug studies, there’s little doubt that specializing in clinical trials of medical devices can be an attractive and rewarding, but very different, rodeo for clinical research professionals to play in.

You’ve probably heard it all before: The clinical research enterprise has a problem with expecting new hires in what are often basically low-paying, entry-level positions to already have two or more years of experience with the position’s duties. It’s a talent acquisition model that does no one any favors, especially at the study site level where a healthy pipeline of new clinical research coordinators (CRCs) would go a long way to alleviating delays in trial conduct. 

Clinical Trial Management Systems (CTMS) are software platforms that provide clinical research sites and research study staff with the ability to manage all operational aspects of a clinical trial, both at the study protocol level and participant level. A CTMS platform can help streamline study start-up processes, provide real-time visibility into the status of a study, improve collaboration through automated workflows, and optimize financial management processes.