By Jennifer Stewart and Trish Rice
Conducting clinical trials of therapeutics and devices can be daunting, and COVID-19 has made this endeavor even more challenging. With the emergence of this pandemic, sponsors and CROs have been tasked with adapting processes, technologies, and training to move studies forward in a dynamic, demanding environment where regulations continue to evolve.
For global studies, this requires practical, flexible approaches that comply with the regulatory guidance in each region or country where participants are enrolled. At Premier Research, our COVID-19 Task Force combed through the relevant regulations to create a consolidated overview of the guidance that is common to all countries, offering a framework for clinical trial conduct that maintains patient safety while optimizing data integrity and minimizing site burden. In this blog post, we share some of our tips for managing pandemic-related disruptions while collecting the information regulatory agencies will require regarding protocol deviations going forward: