The U.S. Food and Drug Administration just issued a call for applications for the next cohort of the Patient Engagement Collaborative (PEC). The PEC, established in 2018 in collaboration with […]
Researchers are using computer models to simulate COVID-19 infections on a cellular level—the basic structural level of the human body. The models allow for virtual trials of drugs and vaccines, […]
“Conflict isn’t always bad,” says Dr. Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, manager of Kelly Willenberg & Associates. She’s a big proponent of what she calls “conflict competence,” or […]
An effective corrective and preventive action (CAPA) plan for clinical trial practitioners focuses like a laser on a protocol deviation’s root cause by relentlessly asking “why did something happen,” says […]
If we as an industry learn anything from battling the COVID-19 pandemic, David Burrow, PharmD, JD, director of the Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation […]