Ennov pharmacovigilance suite
Next Generation PV Reporting Software
- Standard XML e-report generation
- Individual or batch submission via integrated gateway
- Multi-lingual paper report creation
- Easy and flexible data querying and extraction
- Multiple report formats including aggregate, summary and metrics
- Full integration with Ennov’s auto-reporting tool
- Ability to monitor case frequencies, report submission status and more
The Adverse Event Reporting Challenge
A New Approach to Regulatory Reporting Compliance
- 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
Fast, Easy and Flexible
New regulatory reporting requirements, communications with business partners and evolving requirements in adjacent industries like medical devices, nutritional supplements and cosmetics can pose significant challenges to product safety and surveillance operations. To address these challenges, PV-Reporter provides an easy way to create customized reports in any language. Report templates can be saved for repeated use drastically cutting report preparation time and leaving more time for higher value activities such as medical case review and analysis.
PV-Reporter 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 (i.e. where a given parameter is considered in combination with a specific search record, e.g. product and product misuse). Enhanced grid presentation outputs with multi-row options for multi-record data (such as products and signs) takes interpreting data to the next level. PV-Reporter enables users to save and share query and report layouts for enhanced team efficiency.