Enhancements in Empirica Signal 9.0

Oracle Empirica Signal is now part of the Oracle HSGBU Cloud (SaaS) offering for medical product safety and pharmacovigilance. Oracle Empirica Signal version 9.0 has the following new features and characteristics.

• Browser support has been enhanced. Oracle Empirica Signal now runs in Google Chrome.
• The new user interface for Signal Review has a modern, visual approach that places all features at your fingertips. The Products and Product-Events Combinations pages provide an overview of all signaling activities. Reviewers can immediately assess review completeness for all products or specific product groupings. The new interface includes multiple indicators for items that require personal attention from the user, such as product-event combinations with alerts that require review. Graphical representations help the user visualize and prioritize their activities.
• The existing signal alert concept has been enhanced.

  Graphical and tabular alert information is provided at all levels of the Signal Review page.

  Alert type rules can be defined in one, central place in the application. Alert types can be defined using a logic format similar to that of the view WHERE clause and can be designated as tracked, so they would contribute to the triage process or be purely informational. Each alert type can be triggered based on a drug's review period or complexity level.

  It is now possible to schedule complexity-based alert type rules based on the following data:

  • The granularity of the signal management configuration defined during install.
  • The value of the new product property called Birthdate.
  • The Periodicity value defined in the alert type rule.
• The existing Signal Review functionality has been improved.

  Oracle Empirica Signal 9.0 improves the selection and filtering of products and events by introducing a new, hierarchical structure. The familiar tabular result display has been augmented with a new card view filtering mechanism that combines numerical, graphical, and other information in a compact format. The review flow has been enhanced to maintain focus when switching between different pages.

• Auditability has been enhanced.

  The existing Signal audit trail has been augmented with new features such as management of product properties and management of alerts.

• The Add and View/Edit Topic pages have been graphically improved.