New Software Development Project Designed to Enable DoD to Provide FDA with Rapid Assessment Capabilities
WALTHAM, Mass.--(BUSINESS WIRE)--Dec. 11, 2008--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(TM) 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 (InFormTM), phase I
clinic automation (LabPasTM), clinical data management
(ClintrialTM), clinical trials signal detection (CTSDTM),
strategic pharmacovigilance (Empirica SignalTM) and Signal
Management, adverse event reporting (Empirica TraceTM),
applied data standards (WebSDMTM) and Web-integrated
interactive response technologies (ClarixTM). 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.
CONTACT: CHEN PR, Inc.
Randy Wambold, 781-672-3119
rwambold@chenpr.com
Source: Phase Forward
