The ascent of the Physician-Sponsored Investigational Device Exemption (PS-IDE) clinical trial has shifted roles and responsibilities for many professionals, says Yuki Kuramochi, BSN, RN, a clinical project manager with the […]
A spate of late 2018 U.S. Food and Drug Administration guidances on gene therapy has significantly changed the 2019 clinical trial landscape, warns Meagan Vaughn, PhD, RAC, a research scientist […]
Tracking key operational indicators such as site activation, enrollment, and monitoring targets can help identify problems in clinical trial projects while they are still relatively tiny and manageable, says Cynthia […]
Study sites that fail to conduct adequate billing coverage analysis are “leaving money on the table,” says Kelly Willenberg, owner of Kelly Willenberg LLC. “We see people who don’t do […]
“Digital technologies are one of the most promising tools we have for making healthcare more efficient and more patient-focused,” U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, told […]