Life Sciences

Oracle Health Sciences Empirica Topics

Oracle Health Sciences Empirica Topics is a Web-based application that allows you to keep track of safety information and actions during a drug safety investigation. It enables topics to be created that are potentially relevant, then enables you to assign each topic to work team members for actions, such as literature searches, data mining runs, meetings or other research-related activities, and the completion of such actions or progression to another set of actions—all of which can be recorded.

Attachments such as documents, graphics, data mining results, URLs, or particular outputs from Oracle Health Sciences Empirica Topics software can be added to a topic or action as part of this accumulating dossier of knowledge. Work teams can be defined within the product, and configurations allow companies to customize the system to adapt to their individual business processes.

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BENEFITS

Facilitates collaboration among work teams and provides knowledge-sharing capabilities
Improves senior management visibility
Increases the ability to rapidly respond to regulatory inquiries
Supports proactive lifecycle risk management
Enables streamlined implementation
Creates a record defining safety topics
Allows collection of evidence during investigations
Supports multiple attachment types: documents, URLs, and direct links to data results
Provides a complete archive/dossier of actions in a 21 CFR Part 11-compliant environment