Veeva Safety Signal is a modern application for signal detection for existing safety databases.
Note: Veeva Safety Signal is available for early adopters only.
About Veeva Safety Signal
Veeva Safety Signal is an application with the ability to detect new, unexpected adverse events or changes in an existing adverse event to a medicinal product. This analysis can occur in postmarketing or during clinical trials. Veeva Safety Signal enables tracking safety risks with the medicinal product and investigating Product-Event Combinations (PECs).
Note: You must also have the Veeva Safety application set up to use Veeva Safety Signal.
Compliance with Multiple Data Sources
Veeva Safety Signal can access PEC data from various sources for signal detection. These sources include pharmacovigilance (PV) data from Veeva Safety, literature data from Veeva SafetyDocs, and data from other health authorities (for example, EVDAS from the EMA).
Configurable Signal Alerts
Various statistical calculations and scores are available for detecting PECs. Your organization’s business rules inform the threshold for signal detection.
Periodic and Ad-Hoc Signal Reporting
Veeva Safety Signal performs signal detection periodically. Signal detection can also be triggered manually for ad-hoc reporting.
Integration with Safety, Safety Workbench & SafetyDocs
A Veeva Safety license is required in addition to a Veeva Safety Signal license in order to perform signal detection on PV data. Optionally, Veeva Safety Signal can be used alongside Veeva SafetyDocs and Veeva Safety Workbench. Following signal detection, users can seamlessly transition to the signal management process using Veeva SafetyDocs.
For more information on licensing other Veeva Safety Suite applications, contact your Veeva Representative.