Introduction

The Oracle Empirica Signal software is a web-based analysis environment for generating statistical scores for combinations of drugs and events in a drug safety database, and for detecting unexpected associations of drugs and events (signals).

If your organization is licensed for Signal Management, users can employ the Signal Management feature in Oracle Empirica Signal on Vigibase data. The feature facilitates ongoing monitoring of safety signals by enabling users to perform statistical analyses on successive releases of the data.

A scripted form of Vigibase Signal Management was originally released in 2005. In scripted Vigibase Signal Management, quarterly refreshes are initiated by running shell scripts on the server. Scripted Vigibase Signal Management can be used with Oracle Empirica Signal versions 7.3.x and above.

Oracle Empirica Signal 9.x introduced a new Vigibase Signal Management that is interactive rather than scripted and Oracle Empirica Signal 9.0 enhanced interactive signal management introducing configurable alerts. Interactive Vigibase Signal Management can be installed with Oracle Empirica Signal 9.1.0.3 and above and requires Vigibase data 2018Q2 or later. If scripted Vigibase Signal Management was used previously, there is an optional conversion process to copy information from the old scripted Vigibase Signal Management into the new interactive Vigibase Signal Management.