Conducting Successful Site Qualification Visits Using Virtual Solutions

By Nancy Woody, MA, PMP, Senior Project Manager and Fran Sawyer, Clinical Team Lead

On-site facility evaluations have historically provided us with the insight necessary to determine site performance and viability for our clinical trials. With decentralized trials as a mainstay of the current clinical research landscape, it’s imperative to leverage the virtual resources available to cultivate those same meaningful evaluations and assessments, safeguarding patient safety and data integrity.  We were able to achieve such success when we completed 12 virtual, customized, site feasibility assessments of facilities located throughout the U.S. for a respiratory study. Given the current resurgence of COVID-19, the safety of site staff and our study team was paramount. To minimize the risk to the sites and our CRAs, we elected to conduct the site qualification visits virtually, which required creating hybrid approaches to utilizing our virtual platforms.