Lifecycle Safety Management
Empirica™ Topics
Empirica Topics is a Web-based application that allows safety professionals to keep track of information and actions related to safety issues. Topics are a collection of information potentially relevant to the investigation of a drug safety matter. Once topics are created, they may be assigned 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—can all be recorded.
Attachments such as documents, graphics, data mining results, URLs or particular outputs from Phase Forward’s Empirica™ Signal product 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.
Why Topics
Empirica™ Topics is a practical tool for managing information and activities relevant to drug safety processes. Topics provides the following benefits:
- Facilitates collaboration among work teams
- Improves senior management visibility
- Increases ability to rapidly respond to regulatory inquiries
- Supports proactive lifecycle risk management
- Streamlined implementation
- A foundational component of the Empirica™ Safety Suite
Topics Features
- Creates a record defining safety topics
- Allows collection of evidence during investigations
- Provides a collaborative, knowledgesharing work team environment
- Supports multiple attachment types: documents, URLs and direct links to Empirica data results
- Provides a complete archive/dossier of actions in a 21 CFR Part 11-compliant environment
