If you’re a Sponsor or CRO, capturing and accessing the required regulatory information for an activation or ongoing study execution can be quite challenging. The sites need to manage and maintain from a regulatory or ISF perspective what’s necessary to be reviewed by the sponsor. This information can be stored in multiple places, emails and portals so often the information is getting lost, it’s hard to know if it’s the right version or even the right information. In the case of master trials, these issues are further compounded.
Without question, clinical trials have been dramatically impacted by the rapid spread of COVID-19. There is even more of a demand during this pandemic for eRegulatory solutions that allow staff involved on all sides of this equation—sites, sponsors and CROs – to do their work effectively and efficiently even while needing to distance from one another.