Evidex Signal Management is a cloud based, software-as-a-service drug safety signal management platform built within the Evidex user interface. Evidex Signal Management is audit-ready and compliant with Good Pharmacovigilance Practices (GVP) Module IX for Signal Management that allows an organization to track and resolve safety signals, inquiries, and other requests.
ESM connects to any number of data sources that users need access to, including but not limited to:
1. FAERS
2. ICSR (Argus, ArisG, Veeva, etc.)
3. Vigibase
4. EVDAS
5. EDC
Evidex Signal Management provides a way to:
Automate signal detection
Serve as a single source of truth for safety signals, as well as drug safety related inquiries and other requests
Track all actions that are performed in the management process of signals, inquiries and requests
Facilitate the workflow necessary around signal detection, validation, prioritization, and resolution