Case Study: a large non-interventional study sponsor streamlines SAE reporting with Clincase

Large Non-Interventional Study sponsor streamlines 15,000 SAE reports with Clincase

A large non-interventional study sponsor in pharmacovigilance faced a labor-intensive challenge in managing an anticipated 15,000 serious adverse events (SAEs). Their manual process of filling out paper forms and reconciling data between different sources was inefficient. They partnered with Clincase to find a solution using its e-clinical technology to streamline SAE reporting and reconciliation.

Clincase implemented a solution that automatically generated dynamic SAE reports from the EDC system and sent them via email to pharmacovigilance and sponsor teams. This automation ensured immediate notification for both initial and follow-up reports. As a result, Clincase enabled smooth and timely SAE reporting required by health authorities and significantly simplified the reconciliation process between data management and pharmacovigilance.