Ennov Pharmacovigilance Suite
Ennov’s Pharmacovigilance suite keeps the collection, management, assessment, and reporting of human or veterinary adverse events in one unified database while also providing advanced signal detection and PV data analysis tools. Our software is currently being used by pharmaceutical, biological and device enterprises, contract manufacturers, CROs and leading health authorities around the world.
- A single authoritative source: Manage and track all pharmacovigilance data within a single, unified database to streamline PV operations and ensure regulatory compliance.
- Improved performance: Eliminate manual, paper-based processes and record keeping. Automate PV case intake to achieve productivity gains.
- Ensure compliance: Gain total confidence that all aspects of achieving and maintaining regulatory compliance, including electronic reporting, will be met.
- Increased visibility: Get a real-time overview of your safety database with dynamic metrics and dashboards.
Aguettant Case Study
Cyrille JEUNE, Regulatory Affairs Systems Manager
Case Intake, Triage, Reporting
Animal and Human Health Pharmacovigilance Software
Our flexible software system designed to support pharmacovigilance business processes and technical services case handling practices, while meeting the associated company safety and world-wide regulatory reporting requirements. Used by pharmaceutical companies, CROs, and Pharmacovigilance outsourcing service providers, the software can record, report, and analyze clinical trial and post-marketing adverse events. Ensures the efficient and accurate intake of PV cases and seamlessly submit safety data to the FDA, EMA or other regulatory authorities worldwide via the supplied E2B compliant gateway. Make controlled assessments and apply standardized coding, all while maintaining complete regulatory compliance. All common single case and aggregate reporting formats are accessible.
Signal Detection & Management
Signal Detection and Management Pharmacovigilance Analysis Software
Implementing a process to identify potential signals is essential. Our comprehensive signal detection and data mining tool is designed for use out-of-the-box by business users. Easily access a broad array of statistics as well as powerful data cubing and visualization functionality. Calculate key statistical measures (PRR, ROR, and MGPS) and apply smart stratification to examine the database and detect where customizable thresholds have been exceeded. A searchable repository of all signal management activity permits the review of previous data and evaluates the evolution of a given signal over time. It includes configurable workflows that are aligned with your risk management processes.