Oracle Empirica Signal offers an analysis environment for exploring post-marketing safety data. The source data may be public, such as the data in the FDA Adverse Event Reporting System (AERS) and Vigibase, or your organization's proprietary Oracle Argus product-safety database.
What is Signal Management?
When using both the Oracle Empirica Signal and Topics modules, an additional capability, known as Signal Management, is available. Signal Management is a set of activities, including automated signal detection, alerting, and review and prioritization, validation, analysis, and assessment with recommendations for action. The goals of Signal Management are to identify new risks associated with a drug or product or determine whether known risks have changed. These risks are then tracked through workup and mitigation using the Topic Management capability in the Oracle Empirica Signal application.
Installing and activating a Signal Configuration and an optional Topic Workflow Configuration (TWC) facilitates Signal Management. Oracle provides out-of-the-box signal configurations for most public subscription data sources, as well as for Argus Mart data; you might also request the creation of custom signal configurations for other data sources.
An Interactive Signal Management configuration lets you manage the signal configuration yourself
Oracle Empirica Signal supports both legacy scripted and new interactive signal configurations. Interactive Signal Management (ISM) allows you to set up, validate, refresh, and update the signal configuration yourself.
For new cloud implementations, Oracle pre-installs interactive signal configurations as applicable for the selected data subscriptions. Existing cloud customers can add an interactive signal configuration to an existing implementation, upgrade a scripted signal configuration to an interactive signal configuration, and update their interactive signal management configurations.