Strategic Pharmacovigilance

Strategic Pharmacovigilance

Empirica™ Signal, the latest release of the pioneering WebVDME data mining and signal management system originally developed by Phase Forward’s Lincoln Safety Group, is an established, award-winning tool that provides a dynamic, visual data mining environment for detecting signals, uncovering patterns and recognizing emerging trends in spontaneous adverse event report data. Together with its Signal Management Module, the Empirica Signal system gives pharmacovigilance professionals – whether in industry or government – the tools they need to effectively manage the review, processing and response to safety signals expeditiously and efficiently.

Empirica™ Signal

The Empirica Signal application supports the detection and quantification of safety signals through the use of advanced data mining techniques applied to a variety of spontaneous reporting databases, including a company’s internal safety database. Using the Empirica™ Signal solution, drug safety scientists gain full access to signal scores and to underlying adverse event report data.


Analysis from the Empirica Signal product can be based on any of the several supported safety databases. These include the FDA’s Adverse Event Reporting System (AERS) and Vaccine Adverse Event Reporting System (VAERS) databases, the Vigibase ADR (adverse drug reaction) database from the WHO Collaborating Centre for International Drug Monitoring, and an organization's proprietary drug safety database.


The product uses a Bayesian data mining algorithm created by Dr. William DuMouchel, to produce statistical scores that objectively quantify the frequency with which a drug is occurring with an event. Drugs found to be occurring at disproportionately high rates, even when rarely occurring, can alert reviewers to a potential safety signal, helping prioritize or accelerate further analysis using traditional pharmacovigilance methods.

In addition to systematizing statistical calculations, the Empirica™ Signal product allows users to review the resulting scores in tabular or graphical format. It provides features to investigate specific data: case series, database queries, and standard and user-designed reports.

New Version 7.0 Features:

  • Topic Tracker - allows safety experts to create rerords of signals and other safety-related topics of interests.
  • Improved drug portal interface - allowing users to review scores in tabular or graphical format and drilldown to the underlying case details.

Produced as output from the Empirica™ Signal product, this graph shows adverse events, reported for a specific drug, that have disproportionately high statistical scores, alerting pharmacovigilance staff that further medical review and investigation may be warranted.

The Empirica Signal application supports the classical Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR), as well as logistic regression.

The Empirica Signal product is in use at seven of the top ten pharmaceutical companies, as well as the FDA and NIH, and the UK’s MHRA.

Empirica™ Signal - Signal Management Module

Once signals have been detected with the Empirica Signal product, drug safety scientists can use the Signal Management module to track and manage those signals. Not all signals identified with the Empirica Signal application represent safety problems for a drug, but managing those signals over time is critical to ongoing strategic pharmacovigilance programs. The Empirica Signal - Signal Management module offers capabilities to help safety reviewers track and document the conclusions of earlier reviews, highlight significant changes over time, and organize workflow.

The Empirica™ Signal application can be used in a 21 CFR 11 compliant environment.