Happy Holidays! The ACRP Holiday Mix has Gone Country!

In honor of our trip to the ‘Music City’ for ACRP 2019, April 12-15, 2019, we’re getting you in the holiday spirit “Nashville style.” Happy Holidays from all of us at ACRP, and we’ll see y’all in Nashville! What a Year It’s Been! 2018 was another transformative year for ACRP and the clinical research community. […]

Edwina McNeill-Simaan, MSHS, CCRP, CCRC, Vanderbilt University Medical Center

PIs Struggle to Meet Daunting Expectations

“All things begin and end with the investigator,” says Edwina McNeill-Simaan, MSHS, CCRP, CCRC, a clinical and translational research coordinator in obstetrics and gynecology at Vanderbilt University Medical Center. However, that doesn’t mean principal investigators (PIs) always know what’s expected of them. Far from it, in fact. “They’re expected to hit the ground running,” McNeill-Simaan […]

Jerry Stein, PhD, ACRP-CP, President, Summer Creek Consulting

Sharing Knowledge Key to Raising Professionalism of Clinical Research Workforce

Sharing knowledge—be it via writing an article for Clinical Researcher, presenting a webinar, or speaking at ACRP’s annual conference—has never been more important than today, says Jerry Stein, PhD, ACRP-CP, president of Summer Creek Consulting and chair of Clinical Researcher’s Editorial Advisory Board. “We’re in a field that’s become more of a profession with well-defined […]

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)) […]