ENNOV PHARMACOVIGILANCE SUITE
Case Intake, Triage, Reporting
Next Generation PV Case
Management Software
- Optimized user interface for efficient data entry
- Flexible case input forms
- Efficient and searchable vocabulary lists
- Speech to text and auto-fill features
- 100% web-based
Case Intake, Triage
Efficient Data Entry of Pharmacovigilance Cases
- 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
This web based application revolutionizes pharmacovigilance case management. The interface has been optimized to meet the specific needs of those users engaged in receiving reports, entering data, and handling case follow-ups. Many functions have been developed in response to actual customer feedback to promote efficiency and improve the end user experience. Traditional PV systems have been focused on the needs of the data reviewers and users responsible for trending and analysis.
Data can be captured in structured format using standard vocabulary lists, with very little end user training. Cases can be captured in local language and automatically translated at the time of import into the PV system. Additionally, the solution can be deployed as a lightweight PDF file or as a dynamic browser-based web form optimized for smartphones and tablets.
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
Report
Next Generation Safety Reporting
Create and submit Adverse Event case reports with a next generation solution. This 100% web-based solution that leverages an elegant and intuitive user interface that instantly generates:
- Paper report outputs such as CIOMS and MedWatch 3500s.
- Electronic adverse event reports in full compliance with the ICH E2B standard (R2 and R3 formats).
- Aggregate listing outputs like PSUR, DSUR, and PBRER
The solution also includes powerful querying capabilities which allows business teams to monitor case handling, track compliance, and execute in-depth trend analysis. Advanced data field linking supports context linked queries. Enhanced grid presentation outputs with multi-row options for multi-record data takes interpreting data to the next level.
Core Capabilities
- Elegant, easy-to-use interface
- Advanced query tool allowing the creation of complex custom queries with additional search operators and logic
- Full support for search wildcards and removal of case sensitivity constraints
- Advanced data field linking to support context linked queries
- Enhanced grid presentation outputs – with multi-row options for multi-record data
- Ability to save and share layouts
- Ability to export parameters and layout definitions
- Standard regulatory extractions – such as PSUR
Key Features
- Dramatically speeds up report generation
- Modern and intuitive layout
- Reduced training overhead to accelerate on-boarding
- Seamless connectivity to PV-Works or PV247
- 100% web-based
- 21 CFR Part 11 compliant
Ennov Pharmacovigilance
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.
Why Choose Ennov ?
Hundreds of corporate customers trust Ennov
Over 20 Years of experience providing software solutions for Life Sciences
250+ life science customers, 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
Available as cloud-based or on-premises deployment
You can switch between deployment options at any time.
We make you autonomous
System configuration and management require no IT skills.
Improved security and optimized performance
Data is hosted locally for total flexibility. Single-tenancy minimizes business interruptions.
Cloud-based or On Premises
Multi-Platform
