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Ennov pharmacovigilance suite

PV-Works
Human Pharmacovigilance Software

  • ICH E2B compliant PV database
  • Simplified MedDRA coding
  • Paper and electronic reporting formats
  • Workflow driven
  • Powerful querying and analysis tools

The Pharmacovigilance Challenge

Developing or implementing a system to collect, manage, report and evaluate patient safety data can be time consuming and expensive. Companies of all sizes need a system that is compliant with global regulations, easy to access and use, fast to implement, and simple to maintain. The system must be affordable, allowing companies of all sizes to deploy a high-quality solution that is cost effective for managing their current caseloads, while also capable of growing with their business.

An ideal system would be flexible, could integrate with other databases, and is designed to manage not only adverse events from clinical trials and those occurring spontaneously in the field but could also manage medical inquiries and product quality complaints for all medical products, including traditional pharmaceuticals, biomedical products and medical devices.

A Comprehensive PV Data Management Solution

PV-Works (human) is a flexible software system designed to support pharmacovigilance business processes and technical services case handling practices, while meeting the associated company safety and world-wide regulatory reporting requirements.

The pharmacovigilance database has been designed around the ICH E2B guideline such that every E2B data field maps to a specific database field. Coding to MedDRA is simple. In addition to paper reporting outputs such as CIOMS and MedWatch 3500s, an electronic reporting function is included. Aggregate listing outputs like PSUR, DSUR, and PBRER are simple to generate using built-in tools.

In addition to simple yet comprehensive data entry and reporting functions, the fully integrated workflow functionality will ensure SOP compliance and that critical reporting deadlines are met. Regulatory compliance is afforded with the adherence to key requirements such as FDA 21 CFR Part 11 and the provision of a full audit trail.

Advanced Capabilities Improve Performance

PV-Works is a process driven system. A purpose-built workflow engine is integrated with comprehensive safety functionality in order to provide management control of pharmacovigilance processes.

The software also includes a wide range of powerful querying functionality, allowing business teams to monitor case handling, track compliance, and execute in-depth trend analysis.

  • Comprehensive data querying and powerful analysis
  • Direct data export to Excel
  • Built-in management reports

PV-Works submits electronic adverse event reports in full compliance with the ICH E2B standard (both R2 and R3 formats are supported). Furthermore, electronic medical device adverse event reports may be submitted to FDA CDRH in eMDR format. The systems is easily integrated with standard AS2 gateway software to manage electronic submissions. Acknowledgement messages and batch submissions are comprehensively handled.

The import of E2B compliant XML formats is also fully supported, allowing receipt of cases submitted to industry directly from Competent Authorities and partners.

Core Capabilities

  • ICH E2B compliant safety data collection and reporting
  • Coding of cases against current MedDRA dictionary
  • Extensive data validation, cross-field checks and use of pick lists
  • Duplicate check functionality
  • Integrated spell checker
  • Integrated query tool
  • Automated letter generation
  • Case data export

Key Features

  • Manages spontaneous and clinical trial adverse events, technical inquiries and product complaints
  • Compatibility with with third-party query and reporting tools
  • Easy to configure workflows that match existing business processes
  • Streamlined case review and data approval concept
  • Supports pharmaceutical, biological, medical device, and cosmetic vigilance
  • Available as cloud-based or on-premises deployment
  • FDA 21 CFR Part 11 compliance

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-based or On Premises

Multi-Platform

ISO 9001:2015 certified

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