Exit Door

One and Done: How Bad Is the PI Turnover Problem

It’s ruefully referred to throughout the clinical trial industry as the “one and done” phenomenon, and it’s a problem that has plagued us for years. The term refers to physicians and other medical professionals who jump into a trial to assume the duties of principal investigators (PIs). Unfortunately, many are completely or relatively inexperienced in […]

FDA Commissioner Scott Gottlieb, MD

FDA Commissioner Challenges Clinical Trial Industry to Embrace New Technologies

“We don’t use technology well in clinical trials to collect information and use it to do quality checks on the data that’s collected,” U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, told an audience at the Reagan-Udall Foundation earlier this month (November 19). Gottlieb advocated a better use of digital tools for capturing […]

FDA Aiming to Modernize Pre-Market Notification 510(k) Program Clearance Pathway

FDA Updates Device 510(k) Approval Regimen to Address Cybersecurity

With an eye on keeping up with advances in medical device technology and addressing cybersecurity concerns, the U.S. Food and Drug Administration (FDA) has rolled out its latest regulatory update outlining what it hopes will become a timelier approach to device review and approval. FDA’s work is an attempt to modernize its Pre-market Notification (510(k)) […]

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FOMAT Medical Research Joins ACRP ‘Partners in Workforce Advancement’ Initiative

The Association of Clinical Research Professionals (ACRP) welcomes FOMAT Medical Research to the ACRP ‘Partners in Workforce Advancement’ (PWA) initiative. PWA is a groundbreaking new initiative to expand the clinical research workforce by bringing together a broad coalition of clinical research stakeholders focused on creating a sustainable workforce for the future. “We are excited to […]

Christine Senn headshot

PIs Welcome New Standards and Certifications

Implementing rigorous standards for the professionalism of principal investigators (PIs) and clinical research coordinators (CRCs) at study sites will help everyone do a better job conducting clinical trials, says Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, chief implementation and operations officer and a member of the Quality Assurance and Compliance Committee at IACT Health. The […]