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Dana-Farber/Harvard Cancer Center Implements Phase Forward's Electronic Data Capture Product for Pediatric Leukemia Study.


WALTHAM, Mass. -- Phase Forward (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that the Dana-Farber/Harvard Cancer Center Dana-Farber/Harvard Cancer Centeris the largest National Cancer Institute (NCI) designated Comprehensive Cancer Center in the nation. Founded in 1998, DF/HCC is an inter-institutional research enterprise that unites all of the cancer research efforts of the Harvard affiliated community.  (DF/HCC DF/HCC Dana-Farber/Harvard Cancer Center (also seen as DFHCC) ) has implemented Phase Forward's InForm[TM] Electronic Data Capture (EDC EDC

See: Export Development Corp.
) product for a 500-subject pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 acute lymphoblastic leukemia acute lymphoblastic leukemia
n. Abbr. ALL
Lymphoblastic leukemia occurring mainly in older adults, characterized by rapid onset and progression of symptoms. Also called acute lymphocytic leukemia.
 (ALL) study.

The DF/HCC, launched in 1999 and supported in 2000 by a Cancer Center Support Grant from the National Cancer Institute (NCI See Liberate. ) as a NCI-designated Comprehensive Cancer Center, is the largest cancer center in the U.S., with more than 900 faculty-level scientists performing clinical, basic and population research. Dana-Farber Cancer Institute is the administrative center of the DF/HCC, which runs approximately 150 investigator-initiated oncology studies at any time, and can have upwards of 450 active studies. These trials test many types of treatments, such as new agents, vaccines, new approaches to surgery or radiation therapy, or new combinations of existing treatments for the different kinds of cancer seen in DF/HCC and affiliated hospitals.

Since standardizing on the InForm product in 2005, DF/HCC has implemented more than a dozen studies using the system. The pediatric ALL study is the largest study undertaken to date at DF/HCC using InForm. Pediatric ALL, a malignant disease of the bone marrow, is the most common form of childhood cancer. The study is designed to both improve survival rates and minimize toxicities associated with therapy.

To date, more than 140 patients have been enrolled in the study, which will ultimately involve more than 500 patients at nine centers in Canada, Puerto Rico and the U.S. When the study began in 2005, data was captured on paper. The DF/HCC team wanted to gain experience with smaller studies using the InForm EDC product before stepping up to this larger, distributed study.

"We are pleased to have converted this study to EDC and are beginning to derive the benefits of InForm, such as greater data visibility earlier in the trial and more accurate data resulting from the edit checks that begin at the data entry stage," said Jane O'Brien, CCRP CCRP College Curriculum Renewal Project
CCRP Command and Control Research Program
CCRP Common Controls Replacement Project
CCRP Certified Clinical Research Professional
CCRP Certified Canine Rehabilitation Practitioner
CCRP C4ISR Cooperative Research Program
, pediatric ALL program manager. "We also value the ability to quickly generate ad hoc reports and to quickly resolve queries."

"Dana-Farber/Harvard Cancer Center is one of the most respected research institutions in the world, and we're honored to serve as a strategic partner," said Bob Weiler, president and chief executive of Phase Forward. "It's no surprise that the rigor and organization that this top-notch team brought to the evaluation process has been translated into a smooth and productive ramp up over this first year."

Path to Success

DF/HCC has more than 400 oncology clinical investigators conducting 133 principal investigator-initiated trials in 2006. The organization handles thousands of case report forms per year, according to Marina Nillni, EDC implementation program manager at DF/HCC.

DF/HCC selected the InForm product after a rigorous evaluation process that measured 12 vendors against 173 weighted criteria, according to Nillni. Key factors included reduced data entry through systems integration, upfront edit checks and improved turnaround for study analysis and reporting. The team evaluated product architecture to ensure that it could scale and be supported easily. DF/HCC also created a category called "business criteria" that measured the vendor's stability, depth and breadth of services, responsiveness and general ability of DF/HCC and the vendor to work together.

Nillni reports that key benefits to date of using InForm include:

* Reducing the time to get data from a study from four weeks with the paper-based system to real-time, which can help to accelerate the trial process.

* Decreasing the amount of time to resolve queries from weeks to hours.

"Our expectations were extremely high, but the results have measured up," said Nillni. "We implemented the InForm product on time and below budget while exceeding performance expectations."

About Dana-Farber/Harvard Cancer Center

The Dana-Farber/Harvard Cancer Center (www.dfhcc.harvard.edu) is an inter-institutional research collaboration that unites the major clinical, population, and basic cancer research efforts of the Beth Israel Deaconess Medical Center Both an international and regional referral center, Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts is a major teaching hospital of Harvard Medical School. It was formed out of the 1996 merger of Beth Israel Hospital (founded in 1916) and , Brigham and Women's Hospital Brigham and Women's Hospital (BWH) is a hospital in the Longwood Area of the Boston, Massachusetts neighborhood of Mission Hill. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare. , Children's Hospital Boston Children's Hospital Boston is a children's hospital located in the Longwood Medical and Academic Area of Boston, Massachusetts. Located at 300 Longwood Avenue, Children's is adjacent both to its teaching affiliate, Harvard Medical School, and to Dana-Farber Cancer Institute. , Dana-Farber Cancer Institute, Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. , Harvard School of Public Health The Harvard School of Public Health is (colloquially, HSPH) is one of the professional graduate schools of Harvard University. Located in Longwood Area of the Boston, Massachusetts neighborhood of Mission Hill, next to Harvard Medical School and Cambridge, Massachusetts, , and Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world . The DF/HCC formally became a National Cancer Institute-designated Comprehensive Cancer Center in 2000.

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]), clinical data management (Clintrial[TM]), clinical trials signal detection (CTSD CTSD Crew and Thermal Systems Division
CTSD Certified Trading System Developer
CTSD Computer Test Sequences Document (NASA)
CTSD Coordinate Transformation System (NASA)
CTSD Combat Training Support Directorate
[TM]), strategic pharmacovigilance (WebVDME[TM] and Signal Management), adverse event reporting (Clintrace[TM]) and applied data standards (WebSDM[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 260 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, Food and Drug Administration, GlaxoSmithKline, Merck, U.K. Medicines and Healthcare Products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. , National Institutes of Health, Procter & Gamble, Quintiles Quintiles Transnational Corp. is a contract research organization which serves the pharmaceutical, biotechnology and healthcare industries. History
Quintiles was founded in 1982 by Dennis Gillings and as of 2007 it has 18,000 employees.
, sanofi-aventis, Schering-Plough Research Institute, Serono and Servier. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. This press release contains express or implied forward-looking statements relating to, among other things, the performance and features of Phase Forward's products and services, demand for 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, the possibility that customers' needs or plans may change over time, and the possibility that the level of demand for Phase Forward's products and services may vary. 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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Dec 13, 2006
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