AE Management

Quintiles Outcome offers adverse event management services, including setting up an automatic notification system to inform the medical monitor (as well as other project, site management, and safety personnel) in the event of serious adverse events (SAEs). When an SAE is reported directly or discovered by our medical monitors, we can follow-up with the site to collect the necessary information to determine seriousness, causality, and unexpectedness and develop a safety narrative. We can also provide electronic reporting information directly on the study portal page, allowing physicians to report an event directly to the regulatory authorities.