Commonwealth Informatics

By David Fram, Vice President Research, Co-Founder, Commonwealth Informatics

A CVW Analytics Case Study

Project Background

Sepsis is a significant public health problem and is a major cause of death in hospitals worldwide. The Centers for Disease Control and Prevention (CDC) define sepsis as “a complication caused by the body’s overwhelming and life-threatening response to infection, which can lead to tissue damage, organ failure and death.” CDC is working to better understand the incidence of sepsis in the population and looking for new ways to rapidly identify and treat the disease. This is challenging, however, since there is no definitive diagnostic test for sepsis. The estimated incidence and mortality rate from sepsis in the US population varies significantly based on the surveillance definition and data source utilized.  Multiple reports based on administrative claims data suggest that there has been a significant increase in recent years in sepsis incidence but it is not clear if this is a true reflection of what is happening in society versus an artifact of inaccuracies related to using claims data for surveillance.

Continue reading Sepsis Surveillance Using Electronic Medical Records and Laboratory Data

Date posted: April 2, 2018 | Author: | No Comments »

Categories: Uncategorized

By Paul Barrow, Associate Director, Commonwealth Informatics

This November marked a significant change for signal management following the EU pharmacovigilance legislation with Marketing Authorisation Holders (MAHs) receiving access to EudraVigilance data for signal detection for the first time.

MAHs will be granted access starting in December.  A one-year pilot starts three months later on 22 February 2018 when MAHs are required for to perform signal detection for a limited set of products.  Continue reading Preparing for EudraVigilance Monitoring

Date posted: December 15, 2017 | Author: | No Comments »

Categories: EudraVigilance pharmacovigilance

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