Ennov PV Case Management
Streamline Adverse Event Processing and Regulatory Reporting
- 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
Ennov’s web-based PV Case Management solution delivers a next-generation, AI-enabled platform for the complete lifecycle management of Individual Case Safety Reports (ICSRs) – from multi-channel intake through processing, review, and global regulatory reporting.
Built for operational efficiency and compliance, the solution combines intuitive UI/UX, workflow automation, wizard-driven guidance data capture, and advanced AI capabilities to streamline pharmacovigilance processes and improve data quality at scale.
Intelligent Case Intake
(Structured & Unstructured Data)
Ennov enables seamless ingestion of adverse event data from any source, supporting both structured and unstructured formats:
- Multi-channel intake
+ E2B(R2/R3) imports (ICH and Local Requirements)
+ Wizard-Driven Case Intake (ideal for Call data entry)
+ Email, PDFs, scanned documents
+ Partner and health authority feeds
- AI-powered data processing
+ Natural Language Processing (NLP) to extract key safety data from narratives, emails, and documents
+ Automated field population from unstructured content
+ Intelligent duplicate detection and case reconciliation
- Structured data capture
+ Configurable forms with controlled vocabularies connected with Regulatory Dictionaries e.g. MedDRA, WHO-DD, or VeDDRA APIs
+ Validation rules aligned with ICH and local requirements
+ Minimal training required due to guided entry
- ICH E2B R3 compliant PV database
- Simplified MedDRA coding
- Paper and electronic reporting formats
- Workflow driven with powerful querying and analysis tools
- Optimized user interface for efficient data entry
Smart Case Processing
(Triage, Time Tracking, and Approval)
Ennov PV Case Management delivers intelligent, AI‑powered case processing to streamline triage, ensure compliance with global timelines, and reinforce data quality through automated controls and guided workflows.
- Time tracking & regulatory compliance
+ Built-in time clock tracking aligned with local and global regulatory reporting requirements+ Automatic monitoring of submission timelines and deadlines
+ SLA-based alerts and escalation to ensure on-time reporting - Quality control (QC) & Approval assistance
+ Embedded auto-validation rules to ensure completeness and consistency
+ Guided section-by-section review
+ Configurable approval workflows with role-based authorization
+ Real-time identification of errors, missing data, or inconsistencies
- Case version control & audit trail
+ Full version management with automatic tracking of case follow-ups+ Maintenance of locked, auditable versions for submissions
+ Complete history of changes and revisions for full traceability
Next Generation Case & Aggregate Reporting
Ennov PV Case Management delivers next-generation regulatory reporting capabilities, combining automation, compliance controls, and scalability to support both individual case reports and aggregate/periodic reporting across global markets.
- Individual Case Safety Reports (ICSRs) from validated case data:
+ E2B(R3) XML electronic reporting with ICH and Regional requirements with acknowledgment (ACK) handlingCIOMS I / CIOMS II reports
+ SUSARs (Suspected Unexpected Serious Adverse Reactions) for clinical trials
+ Expedited adverse event reports
+ Serious and unexpected reaction reports
+ Follow-up reports
+ Amendment and nullification reports - Aggregate & periodic reporting
+ PSUR / PBRER (Periodic Benefit-Risk Evaluation Reports)
+ DSUR (Development Safety Update Reports)
+ Signal evaluation outputs and risk summaries
+ Line listings and cumulative summary tabulations - Submission management & compliance
+ Centralized tracking of reporting timelines and submission status
+ Configurable workflows for health authority and partner reportingSubmission through PV Gateways
+ Full audit trail for all submissions to ensure inspection readiness
- Blinding / unblinding data management
+ Structured handling of blinded and unblinded data+ Controlled unblinding request workflows with full traceability
+ Protection of study data integrity, align with GDPR regulations - Data confidentiality & sub-setting controls
+ Role-based access control (RBAC) to restrict visibility by user, role, country, or partner+ Data sub-setting to ensure users only access relevant cases or fields
+ Support for masked or anonymized data views when required
+ Secure collaboration with internal teams and external partners while maintaining confidentiality - Automation and AI-powered features
+ Automated case prioritization based on seriousness, expectedness, and regulatory timelines+ AI-driven duplicate detection and case matching
+ Intelligent support for initial case assessment and classification
Business Benefits
By implementing Ennov PV Case Management organizations can:
Ennov PV Case Management provides a centralized, compliant environment for managing safety cases from initial receipt through regulatory reporting, enabling organizations to efficiently meet global pharmacovigilance obligations while maintaining high standards of patient safety.
- Improve regulatory compliance
- Reduce manual processing effort
- Increase case quality and consistency
- Accelerate reporting timelines
- Enhance inspection readiness
- Improve patient safety monitoring
- Increase operational efficiency across global safety organizations
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?
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