While COVID-19 has frozen much of the world, healthcare marches on. The studies that will determine the safety and efficacy of health-improving and life-saving drugs must continue. But now, attending scheduled site visits and collecting critical information from patients have become safety issues for patients and trial staff alike.
How can trial sponsors, whose missions are driven by a need to safeguard patient safety, continue to collect the high-quality data so central to their trials without compromising their safety standards? What must sponsors consider—from both a regulatory and an operational perspective—amid this new normal? And how will the changes made today affect the clinical trials of tomorrow?
RWS and Medidata both support the important work clinical trial sponsors continue to undertake, even in unprecedented times. Together, we have explored these and other questions in service of our sponsor clients and, ultimately, the patients at the center of these conversations.