Ennov PV
Signal Detection and Management
Identify, Evaluate, and Manage Emerging Safety Risks
Ennov Signal Detection and Management is a comprehensive pharmacovigilance analytics platform designed to help life sciences organizations proactively identify, analyze, and manage potential safety signals across large volumes of adverse event data. Built on the Ennov platform, the solution combines advanced statistical signal detection algorithms, flexible data exploration tools, configurable analytics, and integration with signal management workflows to support a complete signal detection process.
- 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
Comprehensive Data Integration
Ennov Signal Detection is designed to ingest data from virtually any adverse event reporting system, including internal safety databases, spontaneous reporting systems, regulatory authority databases, literature sources, and other pharmacovigilance data repositories. Using Ennov’s integration framework, organizations can establish both full and incremental data synchronization processes to ensure signal detection activities are always based on current safety information. The solution supports standardized product dictionaries and both MedDRA and VeDDRA terminology, enabling consistent analysis across human and veterinary pharmacovigilance environments.
Advanced Statistical Signal Detection
At the core of the platform is a robust signal detection engine that supports both frequentist and Bayesian disproportionality analysis methodologies commonly used in global pharmacovigilance programs. Supported algorithms include:
- Proportional Reporting Ratio (PRR)
- Reporting Odds Ratio (ROR)
- Observed-to-Expected Ratio (OE)
- Chi-Square Significance Testing
- Chi-Square with Yates Correction
- Information Component (IC)
- Empirical Bayesian Geometric Mean (EBGM) using the MGPS algorithm
These methodologies help safety teams identify drug-event combinations that occur more frequently than expected and may warrant further medical evaluation.
Integrated Signal Management
Ennov Signal Management is a configurable workflow-driven solution built on the Ennov platform that enables pharmaceutical and veterinary organizations to document, evaluate, assess, review, approve, and track pharmacovigilance safety signals from initial identification through final resolution. The solution provides a centralized, fully searchable repository of signal-related activities, ensuring regulatory compliance, inspection readiness, and complete traceability throughout the signal lifecycle.
Centralized Signal Lifecycle Management
Ennov Signal Management supports the end-to-end investigation of safety signals originating from multiple sources, including:
- Adverse event case reports
- Signal detection and data mining activities
- Periodic safety reviews and trending analyses
- Product quality complaints
- Social media monitoring
- Regulatory authority observations
- Clinical and post-marketing safety data
The system provides a structured framework for managing each signal as it progresses from an initial hypothesis through evaluation, assessment, decision-making, and closure.
Complete Traceability and Inspection-Readiness
A core objective of Ennov Signal Management is to provide complete documentation and oversight of all signal management activities. Every action, review, assessment, approval, and supporting document is maintained within a centralized repository that can be searched and reviewed at any time.
This enables organizations to:
- Demonstrate regulatory compliance
- Maintain a complete audit trail
- Review historical signal decisions
- Analyze signal evolution over time
- Support health authority inspections
- Preserve institutional knowledge
The system serves as a permanent record of signal investigations and their outcomes.
Business Benefits
By implementing Ennov PV Signal Detection and Management software, organizations can:
Ennov PV Signal Detection and Management provides a structured, compliant, and data-driven approach to identifying and managing potential safety risks, enabling organizations to make informed decisions and maintain continuous oversight of product safety throughout the product lifecycle.
- Identify emerging safety risks earlier
- Improve patient safety monitoring
- Standardize signal management processes
- Reduce manual effort and administrative burden
- Enhance regulatory compliance
- Improve inspection readiness
- Strengthen benefit-risk evaluation activities
- Increase visibility into product safety profiles
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 frequently used data
- Speech to text for narratives
- Social style case management tools
Key Features
- Data entry interface is configured to mirror call flow
- Dramatically speeds up data entry
- Modern and intuitive layout
- Optimized for call center operations
- Reduces training overhead and accelerates on-boarding
- Seamless connectivity to PV-Works
- 100% web-based
- 21 CFR Part 11 compliant
How a Global Pharma and Animal Health Leader Migrated 1M+ Safety Records to the Cloud
When infrastructure modernization meets zero tolerance for downtime
From Vendor Frustration to Compliance Confidence
How a Human Pharmacovigilance Services Provider Found a Long-Term Platform and Partner
An End-To-End Solution for Collecting, Reporting and Analyzing Human and Vet PV Data
The Ennov Pharmacovigilance solution keep 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.
Why Choose Ennov
Over 500,000 users trust Ennov
Over 500,000 users trust Ennov
- Over 25 years of experience providing software solutions for Life Sciences and 450+ Life Science customers, with many more in other industries.
- Modern architecture and interface 100% web-based. Highly scalable. User-centric design.
- Our commitment to your success Very high customer satisfaction, 98.5% of projects delivered on time and within budget.
Providing you freedom of choice
Providing you freedom of choice
- Available as cloud-based or on-premises deployment, you can switch between deployment options at any time.
- System configuration and management require no IT skills, making you fully autonomous
- Improved security and optimized performance. Data can be hosted locally for total flexibility. Single-tenancy minimizes business interruptions.
Cloud-based or On Premises
Multi-Platform
ISO 9001 & 27001 Certified
How can we help you?
Fill out the form and we'll be in touch.