Serious Adverse Event (SAE)

Serious Adverse Events (SAE) is used by ORA's Product Safety Surveillance Office for FDA regulated studies. The primary objective of the SAE system is to improve the effectiveness, efficiency, and regulatory compliance with real-time reporting of the adverse event. The SAE system is 21 CFR Part 11 compliant.

Training & Demos

A variety of training options and demos are available for SAE.

If you would like to schedule a demo or training, or have any questions, please contact us.