Ennov Pharmacovigilance Suite
An AI-powered, end-to-end solution for collecting, reporting and analyzing human
and vet PV data
Used by pharma companies, CROs, and health authorities around the world, Ennov’s AI-powered Pharmacovigilance suite brings everything together (from case intake to signal detection) in one unified system. You can collect, manage, assess, and report human and veterinary adverse events in one seamless workflow — with built-in tools for advanced analysis and smarter decisions.
Benefits
- 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 and reporting 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.
Come join more than 450 Life Sciences companies around the world being powered by Ennov
PDS Case Study
“We were happy to find the support and respect Ennov demonstrated, which we felt was quite rare in a shared business partnership.”
Phil Turner,
Business Development Manager Pure Drug Safety
Doc for Pharmacovigilance
Centralize your PV documentation in one compliant system
Ennov Doc for PV centralizes documents and the PSMF, while supporting agreement management in a structured repository built for compliance.
Why teams choose Ennov Doc for Pharmacovigilance:
- Stay inspection-ready with one system for PV documents, PSMF, and agreements
- Reduce compliance risk with controlled lifecycles, ownership, and audit trails
- Keep the PSMF audit-ready with a structured binder aligned to global requirements
- Centralize submissions and reports to support global PV reporting needs
- Manage risk documentation consistently across global and local teams
- Meet 21 CFR Part 11 with compliant controls for regulated PV work
Case Intake & Management
Capture confidently. Configurable workflows. Stay compliant.
Efficiently manage human and animal pharmacovigilance case data from any source (clinical trial or post-marketing) with Ennov’s AI-powered, flexible, compliant solution. Import reports in various formats or enter them directly using fast, intuitive templates. Configurable workflows keep cases on track from intake through coding, assessment, and reporting.
Why teams choose Ennov for case intake and management:
- Accurately capture and manage both human and veterinary PV cases
- Import adverse event data or enter directly using flexible templates
- Fully configurable workflows to support end-to-end case processing
- Seamlessly integrates into existing pharmacovigilance operations
- Trusted by pharma, CROs, service providers, and regulators
- Scalable, compliant, and designed to fit your business processes
- AI-powered data extraction and triage to streamline intake and prioritize high-risk cases
Reporting & Data Analysis
Compliant by default. Fast by design. Global by nature.
A compliant, easy-to-use pharmacovigilance tool giving you flexibility, automation, and confidence — without the typical complexity of reporting.
Why teams choose Ennov for compliant reporting and analysis:
- Generate data extracts, paper reports, and XML submissions with ease
- Analyze safety data using pre-supplied or custom-built queries
- Seamlessly submit to global health authorities including FDA and EMA
- Integrated E2B-compliant gateway streamlines electronic submissions
- Supports all standard single case and aggregate reports
- Offers both manual and automated generation and submission options
Signal Detection & Management
Spot the signal. See the trend. Stay ahead.
Intuitive analysis helps you identify trends, track signal activity over time, and stay aligned with internal risk processes. All without complex setup or customization.
Why teams choose Ennov for Signal Detection and Management:
- Out-of-the-box signal detection and data mining for business users
- Access to advanced statistics, data cubing, and visualizations
- Calculate PRR, ROR, and MGPS to assess safety signals
- Apply smart stratification to surface threshold-based trends
- Searchable repository to track and review signal evolution
- Configurable workflows aligned with internal risk processes