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Introduction
The 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).
The Empirica Signal application supports data from the FOI (Freedom of Information) FDA spontaneous adverse event reports database distributed by NTIS (National Technical Information Service) and prepared by Oracle for use with Empirica Signal. Users access the data in Empirica Signal by using the AERS data configurations.
If your organization is licensed for Signal Management, users can employ the Signal Management feature in Empirica Signal on AERS 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 AERS Signal Management was originally released in 2005. In scripted AERS Signal Management, quarterly refreshes are initiated by running shell scripts on the server. Scripted AERS Signal Management can be used with Empirica Signal versions 7.3.x and above.
Empirica Signal 8.1.1 introduced a new AERS Signal Management that is interactive rather than scripted. Interactive AERS Signal Management can be installed with Empirica Signal 8.1.1 and above and requires AERS data 2017Q3 or later. If scripted AERS Signal Management was used previously, there is an optional conversion process to copy information from the old scripted AERS Signal Management into the new interactive AERS Signal Management.
