Sending Out an SOS for Soft Skills

Clinical Researcher—September 2021 (Volume 35, Issue 7) A NEW E-R-A IN CLINICAL PROJECT MANAGEMENT Zoran M. Pavlovic, MD   Periods of crisis, extreme uncertainty, and severe threats to corporations experienced due to globalization, several economic recessions in the last two decades, and most recently the COVID-19 pandemic negatively impacted the conduct of clinical trials worldwide. […]

CRDSA: A New Collaboration to Advance Clinical Research Data Sharing

As clinical research professionals, we understand the value of patient-donated data. Clinical trials can be time-consuming and sometimes onerous for patients, so we owe it to patients to use their data to the fullest extent possible. There is a lot of emphasis on using real-world data in drug development, but data from clinical trials are […]

David Burrow, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

FDA Emphasizes Importance of Quality in Clinical Trial Design

“Focus on building quality into the clinical trial process through proactive compliance rather than ‘inspecting’ quality in,” David Burrow, director of the Office of Scientific Investigations within the Office of Compliance at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), told attendees of the ACRP 2021 virtual conference […]

Eric Pittman, Director of Bioresearch Monitoring Division (West), U.S. FDAFDA

Are You Prepared for an FDA Inspection?

Nearly half of attendees polled at the ACRP 2021 virtual conference yesterday (September 16) were either only “somewhat” (36%) or “not at all” (9%) prepared when the U.S. Food and Drug Administration (FDA) called to say an inspection was coming. The result wasn’t overly surprising to speaker Eric Pittman, director of the agency’s Bioresearch […]

Rutgers University Showcases How the Pandemic Has Changed Clinical Trials

Rutgers University has pioneered a decentralized approach to clinical trials that is allowing researchers to achieve better scientific outcomes as they accelerate the pace of finding cures, recruit lower-income and underrepresented populations that were previously unable to engage in clinical trials, and broaden the geographic coverage of studies. “This approach that speeds the process of […]