Ennov PV Signal Detection and Management

Ennov PV Signal Detection and Management offers a comprehensive solution for identifying and managing pharmacovigilance signals. Designed for business users, it features extensive statistical measures, including PRR, ROR, and MGPS, which are commonly utilized by regulatory authorities. The application enables rapid calculation of these metrics and allows for smart stratification to detect cases where customizable thresholds are exceeded.

It integrates easily with various pharmacovigilance solutions and external data sources to provide flexibility in metric preparation. A user-friendly dashboard gives an overview of signals at various stages of progression, and a fully searchable repository allows users to review historical data and track the evolution of signals over time.

The software supports configurable workflows that correspond to your risk management protocols, ensuring a thorough signal evaluation and analysis process. Upon signal workup completion, a ‘Signal Summary Report’ is generated, offering a detailed account of the identification and the data collected.

Additional features include a pre-configured document inventory, advanced lifecycle management, flexible rights management, and automatic PDF rendering. The platform also integrates with Ennov's other products for qualitative and quantitative adverse event data review, with automated usage of REST API to record signal data and determine risk levels.

Key Features

• Integrated worklist dashboard.
• Configurable document types, workflows, and views.
• Automated email notifications.
• Intuitive user interface and PDF viewer.
• 100% web-based and 21 CFR Part 11 compliant.

The system supports cloud-based or on-premises deployments, offering ISO 9001 & 27001 certified operations and is designed to be highly scalable, with an emphasis on user-centric design and security. It allows for total flexibility with options for local data hosting and minimized business interruptions through single-tenancy.