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Phase Forward Introduces WebVDME 6.0 – A Pharmacovigilance and Signal Management Product

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Phase Forward, a provider of data management solutions for clinical trials and drug safety, has announced the availability of WebVDME™ 6.0, the latest release of the company’s strategic pharmacovigilance and signal management product.

The new release includes more tools and features for discovering and investigating signals in greater depth, exploring varied combinations of factors that trigger adverse events and simplifying analysis of safety data.

WebVDME is used by pharmaceutical and biotech companies as well as several regulatory agencies, many of which participated in the project as development or testing partners.

“Our goal with this release is to make the WebVDME product even more flexible and intuitive, so that safety evaluators and medical reviewers can easily investigate a signal in terms of the adverse events involved, assess the interactions of multiple drugs and determine the influence of other characteristics in different combinations,” said Chan Russell, president of Phase Forward’s Lincoln Technologies safety division.

“This enables safety professionals to more fully understand the data that is available to them and conduct the analysis they need to make timely business decisions regarding product safety – and even possibly prevent patient exposures if product risks are discovered earlier than they would have been without the use of WebVDME.”

The FDA has implemented the WebVDME system for production and use by safety evaluators and epidemiologists.

“Understanding the data behind the differing and continuously evolving safety profiles of drugs is important for helping make better treatment selections and regulatory decisions,” notes an August 2006 review committee report from the FDA’s Center for Drug Evaluation and Research.