Vault Safety Signal is a modern application for signal detection for existing safety databases.
About Vault Safety Signal
Vault 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. Vault Safety Signal enables tracking safety risks with the medicinal product and investigating Product-Event Combinations (PECs).
Note: You must also have the Vault Safety application set up to use Vault Safety Signal.
Compliance with Multiple Data Sources
Vault Safety Signal can access PEC data from various sources for signal detection. These sources include pharmacovigilance (PV) data from Vault Safety, literature data from Vault 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
Vault Safety Signal performs signal detection periodically. Signal detection can also be triggered manually for ad-hoc reporting.
Integration with Safety, Safety Workbench & SafetyDocs
A Vault Safety license is required in addition to a Vault Safety Signal license in order to perform signal detection on PV data. Optionally, Vault Safety Signal can be used alongside Vault SafetyDocs and Vault Safety Workbench. Following signal detection, users can seamlessly transition to the signal management process using Vault SafetyDocs.
For more information on other Vault Safety Suite applications, contact your Veeva Representative.