Streamline Review of EudraVigilance Data with Commonwealth Vigilance Workbench (CVW) – Investigate
WALTHAM, MA, June 25, 2018 – Commonwealth Informatics, a leading provider of innovative cloud-based products and services for medical product safety and public health surveillance, today announced CVW Investigate, a cloud-based software service that helps customers successfully meet European requirements to monitor the safety of their products using data from the EudraVigilance Data Analysis System in the form of electronic Reaction Monitoring Reports (eRMRS). The CVW Investigate module is part of an integrated technology platform for life sciences companies and regulatory agencies designed to assess analytical evidence for safety from multiple sources of data rapidly and efficiently while in compliance with regulations.
CVW Investigate promotes a comprehensive, timely, and streamlined review:
- Provides a single environment for the review of statistical and non-statistical alerts from all sources (including EudraVigilance)
- Stores and documents a signal detection plan with selection criteria for the subset of statistical alerts that require review
- Presents alerts from all sources in the context of therapy-event pairs
- Offers a rich set of graphical visualizations to support decision making
- Captures the actions taken and produces reports that demonstrate compliance with procedures
- Manages a flexible workflow driven by the priority of each alert and signal
- Interfaces with source systems such as the EudraVigilance Data Analysis System (EVDAS) to provide seamless access to case data
- Delivers a consistent view of events even as the MedDRA dictionary evolves across version upgrades
CVW Investigate can help your organization take full advantage of new surveillance resources such as EudraVigilance while streamlining the work of safety reviewers. For more information or to request a demonstration, please contact Michelle Tully, firstname.lastname@example.org, 978-606-7682.
About Commonwealth Informatics:
Commonwealth Informatics is a leading technology and services company with industry expertise in medical product safety and public health surveillance. Pharmaceutical and biotechnology companies, government agencies, and healthcare providers use Commonwealth’s products and services to assemble data and answer complex clinical analysis questions quickly and accurately.
Sarah Cropp @ email@example.com