Ennov pharmacovigilance suite

PV-Reporter
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

On-time, complete and accurate reporting of adverse events is essential for regulatory compliance in Pharmacovigilance. Without proper tools, this rote administrative task can consume your organization’s valuable time and resources. The time spent manually creating regulatory reports, querying data, and formatting outputs might otherwise be directed to higher value activities that can have a material impact on your company’s overall performance.

A New Approach to Regulatory Reporting Compliance

PV-Reporter is Ennov’s next generation solution for creating and submitting Adverse Event case reports. PV-Reporter is a 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
Electronic Medical Device AE reports can also be submitted to FDA CDRH in eMDR format. PV-Reporter is easily integrated with any standard AS2 gateway software to manage electronic submissions. Acknowledgment messages and batch submissions are fully supported.PV-Reporter also provides the ability to import E2B compliant XML formats, allowing receipt of submitted cases directly from Competent Authorities and partners.

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.

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

Why Choose Ennov ?

Hundreds of corporate customers trust Ennov

Over 19 Years of experience providing PV solutions

150+ 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 industries

Cloud-based or On Premises

multiplatform

Multi-Platform

iso 2015 ready

ISO 9001:2015 certified

Stop wasting your valuable Pharmacovigilance resources on repetitive and low-value activities

Do not miss our tour of our innovative solution !
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