MHRA - the U.K.'s Medicines and Healthcare Products Regulatory Agency - Implements Phase Forward Technology for Enhanced Safety and Risk Detection
WALTHAM, Mass.--(BUSINESS WIRE)--Feb. 17, 2006--
Phase Forward's Lincoln Technologies WebVDME(TM) Supports More Efficient Pharmacovigilance
Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA), the U.K.'s regulatory agency, has implemented the company's Lincoln Technologies pharmacovigilance signal detection and signal management product, WebVDME(TM). The software will be used by MHRA clinicians, pharmacists and scientists to examine reports of suspected drug side effects from medicines received through its Yellow Card Scheme, a system used to collect information on suspected adverse drug reactions.
Phase Forward's Lincoln Technologies product is expected to enhance the Agency's ability to use adverse drug reaction reports more efficiently to identify and prioritize potential safety issues. The software combines advanced statistical signal detection methods with access to the Yellow Card report data, and powerful new analysis tools in the routine review of drug safety information. The software's ability to present the latest new information in the context of historic data for both U.K. and non-U.K. reports enables faster access to the information needed to make objective assessments based on scientific evidence, providing opportunities for greater efficiency in its signal detection processes.
Dr. June Raine, director of post licensing at the MHRA, said, "This innovative technology will provide valuable new tools for improving the safe use of marketed medicines. It will help us continue to strengthen processes for identifying possible risks to public health more quickly and efficiently, and will keep us at the forefront of signal detection."
"The MHRA selected us through a tough and competitive procurement process, which included extensive pilot testing of Lincoln's tools by MHRA staff," said Bob Weiler, president and chief executive officer, Phase Forward. "We look forward to working closely with the MHRA to continue enhancing our tools and advancing the state of the art in pharmacovigilance. We are proud that the combination of our software development and statistical research is being applied to further the goal of patient safety."
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.
About the Medicines and Healthcare products Regulatory Agency (MHRA)
The MHRA is the U.K. government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all MHRA's work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. The MHRA keeps watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. The MHRA aims to make as much information as possible publicly available. MHRA's home page is www.mhra.gov.uk.
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 business and operations plans of a Phase Forward customer, and the ability of Phase Forward's customers to realize benefits from the use of Phase Forward's products and services. 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's customers to realize benefits from the use of its products and services, and the possibility that customers' needs or plans may change over time. 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.
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