Track and resolve safety signals from any data source with audit-ready and intuitive tools. Fully validated off-the-shelf based on GVP Module IX signal management guidelines. Flexible enough to meet any organization’s unique needs. Fast, compliant, and lean implementation. Integrated and automated signal detection provides a holistic and modern approach to pharmacovigilance.
Track signals from any data source alongside internal and external inquiries and requests.
Link signals, inquiries, and requests together for a full view into how an issue is being handled.
Actions are logged to create an audit trail. Future Actions can be created and assigned to responsible persons for an infinitely configurable workflow.
Seamless integration between signal detection and signal management enable tracking on any dataset. Ability to manually add signals provides for complete flexibility.
Customizable filters and detailed user level tracking ensure regulatory compliance.
Evidex is cloud-native, software-as-a-service built on next generation technology with a best-in-class user interface minimizing resources needed for implementation and providing tools safety reviewers want to use.
Your Evidex Product Specialist is always available to train new users, conduct refresher sessions, or answer questions on-demand. In-app chat support is available in Evidex as is an interactive, online user guide.
Signal detection and advanced analytics on FDA Adverse Event Reporting System (FAERS), WHO's VigiBase, and our proprietary clinical safety database are included from Day 1.