Commonwealth Informatics Announces New Product Offering: Commonwealth Vigilance Workbench (CVW) for EudraVigilance
New Offering Provides Medical Product Market Authorization Holders (MAH) in Europe with Software Platform for Screening Surveillance Statistics from the EudraVigilance Data Analysis System (EVDAS)
WALTHAM, MA, October 26th, Commonwealth Informatics, a leading provider of cloud-based clinical and safety analytics products and services, today announced a new product offering, CVW for EudraVigilance, which helps medical product developers comply with new reporting requirements defined in the EU Pharmacovigilance Legislation. The CVW for EudraVigilance offering from Commonwealth Informatics supports safety teams in the efficient review of electronic Reaction Monitoring Reports (eRMR) from EVDAS and allows results to be integrated into their existing signal management process.
During the 4th quarter of 2017, Marketing Authorization Holders (MAHs) in Europe will be required to identify, validate and monitor signals from the EudraVigilance Data Analysis System (EVDAS) per the legislation. Safety teams will be obligated to access EVDAS and use the (eRMR) and other tools to perform safety surveillance and analysis for their products from EVDAS. The new data source will be downloaded from EMA and will be available and updated regularly. Analysis of the new data source may require manual analyses by safety reviewers and comparisons with safety signals that are being tracked with existing safety signal detection systems that are not designed to incorporate this new data source.
The Commonwealth Vigilance Workbench (CVW) streamlines and supports a compliant safety signal management process from signal detection to submission-ready output. The CVW Investigate module allows pharmacovigilance teams to import signal detection statistics and efficiently filter and review those statistics to meet safety signal detection requirements. CVW Investigate can handle a wide range of data sources and signal detection methods including the eRMR Reports from the EVDAS. The CVW for EudraVigilance offering provides safety teams with a fully hosted software platform pre-configured to screen the statistics coming from EVDAS for their organization’s marketed products. The offering is fully managed and supported by Commonwealth.
“The EVDAS system provides European marketing authorization holders with a new source of signal detection statistics to monitor the safety of their medicines. We developed the CVW for EudraVigilance offering to help clients take advantage of this new data stream while maintaining audit trails, traceability and compliance with existing processes” said Geoff Gordon, Commonwealth Informatics President. “It provides an easier way for safety teams to interact with EVDAS reports and integrate results with data from other signal detection sources and systems.”
About Commonwealth Informatics
Commonwealth Informatics is a 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 relevant data and answer complex clinical and safety analysis questions quickly and accurately. Learn more about the innovative products and services that are helping to improve the speed and accuracy of clinical data analysis at http://www.commoninf.com.