By Nick Poulson, Senior Project Manager; Fran Sawyer, Clinical Team Lead; and Alexa Mulrath, Clinical Team Lead
The Problem: COVID-19
With Studies 1 and 2 approximately 4 months away from an interim database lock and Study 3in startup, the COVID-19 pandemic put the entire program at risk. For all three studies, the Sponsor relied on our teams to find creative solutions around site availability, patient retention, and remote monitoring of the data that would ensure patient safety, data quality, and allow study
progression to continue without delay, while remaining in accordance with pandemic-related FDA guidelines. We needed to customize and implement our virtual, multi-layered solution quickly and seamlessly.
Use a three pronged approach to address new pandemic-induced risks by assessing:
- Patient Impact
- Site Impact
- CRO/Sponsor Impact