Commonwealth Informatics

A Solution for EudraVigilance that Complements Your Existing Signal Management Processes 

Beginning in November of 2017, Marketing Authorization Holders (MAHs) in Europe will be required to identify, validate and monitor signals from the EudraVigilance Data Analysis System (EVDAS). Safety teams will be obligated to access EVDAS and use the electronic Reaction Monitoring Report (eRMR) and other tools to perform signal detection from EVDAS.

To help medical product developers comply with the new regulation, Commonwealth developed the Commonwealth Vigilance Workbench (CVW) for EudraVigilance offering which provides users with the CVW Investigate Module to efficiently filter and review their EVDAS data in a manner that is available for process management and provides inspection evidence. CVW for EudraVigilance allows safety teams to incorporate the EVDAS data streams while complying with existing signal management processes and workflow. 

CVWInvestigate2

(Click to Enlarge). This screen is an example display of eRMR statistics and reference data for use by the safety reviewer is shown in the image below.

The CVW for EudraVigilance is a Software as a Service (SAAS) offering that is fully hosted and managed by Commonwealth Informatics. Users simply require access to the Internet, and a modern web browser . 

How it Works

1) Define an agreed to method for conducting the monthly upload of the EVDAS files to CVW Investigate. CVW Investigate will then maintain an analysis database of all of the eRMR statistics. 

2) Configure CVW Investigate to select the drug-event combinations with defined statistical alerts of drug-event combinations.

3) Include any needed reference data of drug-event combinations already identified as possible signals which may be under investigation in other systems.

4) Login regularly to CVW Investigate to review, set the disposition and record any outcomes related to alerts in the system.

Key Benefits 

  • Rapid Compliance  eRMR statistics are readily available for use during signal assessment in a system that provides evidence of review including audit trials of decisions on alert disposition
  • Reduced Costs – Comply with the new legislation without adding new systems, people or infrastructure 
  • Reliable Results –  CVW Investigate delivers efficient signal management and is supported by the proven team of signal detection software development experts at Commonwealth. 

Learn More 

For a demonstration of how the CVW for EudraVigilance can be applied to your EVDAS data, contact us.