Ennov PV Case Intake & Management

The Ennov PV Case Intake & Management application offers a comprehensive solution for pharmacovigilance case management, effectively capturing, triaging, and managing adverse event reports to ensure compliance and data integrity. It provides customizable workflows to support the complete case processing lifecycle, seamlessly integrating into existing pharmacovigilance operations.

This web-based application is tailored for users involved in report reception, data entry, and case follow-ups, with many functionalities developed from user feedback to enhance efficiency and user experience. Unlike traditional systems focused on data reviewers, it supports structured data capture using standard vocabulary lists, minimizing training demands and allowing cases to be recorded in local languages with automatic translation upon import.

The system features an ICH E2B R3 compliant database, simplified MedDRA coding, and accommodates both paper and electronic reporting formats. It is workflow-driven, providing potent querying and analysis tools, with an interface optimized for swift and effective data entry.

Core Capabilities

• Optimized case capture interface
• Search engine style querying
• Configurable data section and field layouts
• Searchable vocabulary lists
• Rapid coding tool
• Drag-and-drop palette for commonly used data
• Speech to text for narratives
• Social style case management tools

Key Features

• Data entry interface mirrors call flow, expediting entry processes
• Modern, intuitive layout ideal for call center operations
• Reduces training needs and speeds up onboarding
• Web-based connectivity with PV-Works
• 21 CFR Part 11 compliant

The Ennov solution unifies the collection, management, assessment, and reporting of adverse events for both human and veterinary cases in a single database, boasting advanced tools for signal detection and PV data analysis.

With over 25 years of experience and serving more than 450 life sciences customers among 500,000 users, Ennov offers a user-centric, scalable design supported by modern architecture. Available as either a cloud-based or on-premises deployment, the system offers flexibility, allowing deployment changes without IT intervention, and features enhanced security and performance.