Cynical, cigar-chomping baseball managers or jaded political campaign hacks might disagree, but nice guys (and women) definitely don’t finish last when it comes to working on clinical trials. Fresh off […]
Site monitoring visit reports are something of an Achilles heel in the documentation of clinical trials, says Roslyn Hennessey, PA, MS, a project manager at Westat. “When we’re talking about […]
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 […]