U.S. Department of Defense Chooses Phase Forward to Support FDA-Sponsored Drug Safety Initiative

Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that it has been awarded a contract by the United States Department of Defense (DoD) to support the Food and Drug Administration’s (FDA) plans to access DoD healthcare data for rapid assessment of drug safety issues. The program will be managed by the Pharmacovigilance Center of the Office of the Surgeon General of the Army, which oversees medical benefits programs for Army personnel.

Phase Forward will also operate a production server facility to support DoD’s Web-based access to the data, as well as provide general support services including training, application assistance and end user support. FDA’s initiative calls for rapid evaluation of DoD healthcare data on Army active duty personnel, their family members and retirees to determine which potential safety "signals” merit a more thorough investigation through an epidemiological study.

"FDA’s data sharing initiative with DoD and other federal partners is an important step forward in drug safety innovation,” said Phase Forward Lincoln Safety Group President Chan Russell. "By partnering with DoD and other healthcare data providers, FDA gains access to a rich and comprehensive set of patient data. We look forward to supporting the DoD and FDA in this important project as part of their efforts to more actively monitor the safety of marketed products.”

The contract calls for Phase Forward to provide a data mining capability suitable for use with longitudinal medical records and insurance claims data. To do so, Phase Forward will enhance its Empirica™ software suite to provide a broad new capability for defining a patient "cohort” -- a designated patient group followed over a period of time -- based on exposure to a particular drug or drugs of interest. The Empirica suite will also analyze the cohort to determine and compare incidences and prevalence of specified safety outcomes with respect to a background or comparator group.

Also according to the terms of the contract, Phase Forward will optimize the Empirica software suite to handle more sophisticated definitions of exposure and outcome, including multiple separate exposures for a patient and concomitant exposure to multiple medications. The software suite will be designed to support outcomes involving the presence or absence of multiple symptoms. The contract also calls for expanded capabilities to refine the selection of patients to be considered for inclusion in a full-scale epidemiological study.

About the Army Medical Department

More information about the Army Medical Department is available at www.armymedicine.army.mil. With the war on terrorism raging, the spotlight justifiably is on the Army's Medics, evacuation units, surgical teams and field hospitals in the theater of war. Yet the Army Medical Department is also a seamless chain of care stretching back to fixed hospitals in Europe and the United States, where Our Wounded Warriors receive state-of-the-art care. Field medical units are under the command of the combat commanders, because their movements and work must be coordinated with those of fighting forces. The fixed hospitals, on the other hand, are commanded by the U.S. Army Medical Command. The challenge for Army medicine is (1) how to provide medical leadership for field units while respecting combat commander's "ownership" and (2) how to integrate the work of field and fixed units.

Visit the Surgeon General's Blog and submit your comments on this week's discussion: 'Access to Health Care'. Please come back often to see what the Army Surgeon General is talking about each week.

Visit links to some of OTSG-supported DOD executive agencies.

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 for electronic data capture (InForm^TM), phase I clinic automation (LabPas^TM), clinical data management (Clintrial^TM), clinical trials signal detection (CTSD^TM), strategic pharmacovigilance (Empirica Signal^TM) and Signal Management, adverse event reporting (Empirica Trace^TM), applied data standards (WebSDM^TM) and Web-integrated interactive response technologies (Clarix^TM). In addition, the company provides services in the areas of application implementation, hosting and validation, data integration, business process optimization, safety data management and industry standards. Phase Forward’s products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 280 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, the U.S. Food and Drug Administration, GlaxoSmithKline, Harvard Clinical Research Institute, Merck Serono, Novartis, Novo Nordisk, PAREXEL International, Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Servier, Tibotec and the U.K. Medicines and Healthcare Products Regulatory Agency. Additional information about Phase Forward is available at www.phaseforward.com.

Note to Editors: The appearance of name-brand products in this press release does not constitute endorsement by the U.S. Army Medical Command, the Department of the Army, Department of Defense or the U.S. Government of the information, products or services contained therein.

Cautionary Statement

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, development plans for future software products and enhanced functionality, expected performance of Phase Forward’s products and services, and product and service requirements issued by U.S. Government agencies. 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 U.S. Government agencies, discontinuation of the use of Phase Forward’s products and services by customers or U.S. Government agencies, the possibility that customers’ and U.S. Government agencies’ needs, plans or requirements may change over time, and the continued availability of contract funding by U.S. Government agencies. 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 Annual Report on Form 10-K, as updated by its most recent Quarterly Report on Form 10-Q.