Product Overview
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.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
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.
About the company
Headquartered in Paris, with offices in the US, UK, and Asia, Ennov provides the most original, comprehensive and cost-effective suite of software solutions for the Life Sciences industry. From leading pharmaceutical companies to emerging biotechs, we proudly serve over 250 companies and 250,000 users around the world.
For more than 20 years, we have been developing innovative, powerful and easy-to-use software for regulated content, data and process management. Our solutions are designed and built to support the entire Life Sciences R&D continuum including Clinical, Regulatory, Quality, Pharmacovigilance and Commercial. Ennov is ISO9001:2015 certified for all software products and processes and we boast a 100% success rate in customer audits.
Our solutions enjoy extremely high user adoption rates, thanks to our intuitive user interfaces and commitment to building solutions that work the way our users work. We also have very high customer satisfaction ratings with an on-time project delivery rate of 98.5% and an annual maintenance renewal rate of 96%.
