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Phase Forward's Safety Data Mining Solution in Production At FDA

Posted on: Thursday, 8 September 2005, 09:00 CDT

Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced the successful completion of recently acquired Lincoln Technologies' Cooperative Research and Development Agreement (CRADA) with the FDA to develop advanced analytical tools for drug safety risk assessment. The project, which began in March of 2003 and involved participation by both the FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), resulted in the development of the Web Visual Data Mining Environment (WebVDME) 5.1 feature set and user interface. FDA is implementing Lincoln's WebVDME system for production and use by safety evaluators and epidemiologists in CDER's Division of Drug Risk Evaluation (DDRE) and CBER's Division of Epidemiology.

The success of Lincoln's CRADA with the FDA is a result of several years of work by the FDA evaluating data mining and associated data visualization techniques as a tool to help safety evaluators analyze spontaneous reports of adverse reactions pertaining to drugs, biologics, and vaccines. Lincoln's data mining technology and specialized graphic visualization tools have been used by the FDA with its Adverse Event Reporting System (AERS) and Vaccine Adverse Event Reporting System (VAERS) database of voluntary adverse reaction reports to help identify unexpectedly frequent combinations of drugs and events and to organize, identify, and interpret patterns in the data.

"We are pleased that our longstanding collaboration with the FDA has resulted in the addition of new data mining capabilities to complement their present pharmacovigilance practices," said Chan Russell, president of Lincoln Technologies. "In addition, our recent merger with Phase Forward brings the additional resources and operational infrastructure necessary to continue to support and build upon the use of WebVDME at the FDA."

The FDA is exploring other areas in which WebVDME may prove useful for safety surveillance, including medication error monitoring, assessment of safety in clinical trials, and signal detection in electronic longitudinal medical records.

About Phase Forward

Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. The company offers proven solutions in electronic data capture (EDC), clinical data management (CDM), and adverse event reporting (AER) to help pharmaceutical, biotechnology, and medical device companies bring needed drugs and therapies to market faster and more safely. Lincoln Technologies, acquired by Phase Forward in August of 2005, delivers solutions for pharmacovigilance, data standardization, and safety signal detection. The combined companies' products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 220 organizations and regulatory agencies worldwide including: AstraZeneca, Biogen Idec, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, FDA, GlaxoSmithKline, Guidant, MHRA, NIH, Procter & Gamble, Quintiles, Sanofi-Aventis, Schering-Plough Research Institute, and Serono. Additional information about Phase Forward is available at www.phaseforward.com.

Certain statements made in this press release that are not based on historical information are forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release contains express or implied forward-looking statements relating to, among other things, the performance of Phase Forward's products and services, future use of Phase Forward's products by the U.S. Food and Drug Administration (FDA), and the ability of Phase Forward to successfully integrate the operations of recently-acquired Lincoln Technologies, Inc. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond Phase Forward's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, the ability of Phase Forward to collaborate with regulatory agencies, discontinuation of the use of Phase Forward's products and services by regulatory agencies such as the FDA, the possibility that regulatory agencies' needs or plans may change over time, and the risk that Phase Forward may not realize the benefits of its recent acquisition of Lincoln Technologies, Inc. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Phase Forward undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by Phase Forward, see the disclosure contained in Phase Forward's public filings with the Securities and Exchange Commission including, without limitation, its most recent Quarterly Report on Form 10-Q.

Source: Business Wire

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