Phase Forward Announces Release of Free Tool to Streamline FDA Submissions

Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced the release of its DefineValidator tool, Release 1.0, as a free download for CDISC adopters. The tool was adapted from a current feature of Phase Forward's WebSDM(TM) product, which was developed under a Cooperative Research and Development Agreement (CRADA) for the FDA to validate and review submission data in CDISC Study Data Tabulation Model (SDTM) format.

The define.xml file is used by the FDA to understand the contents of CDISC SDTM submissions, and is necessary to load clinical study data into the FDA's Janus data warehouse. Problems with the file can delay loading of submission data into Janus and make it difficult for reviewers to understand SDTM data submissions. Unfortunately, many of these files received to date by FDA have been problematic, partly due to the lack of a widely available validation tool that can be used by most sponsors. Phase Forward's DefineValidator tool is designed to help sponsors identify and correct define.xml errors prior to submitting to FDA, which should streamline the submission process for both parties.

"We're very pleased that Phase Forward has contributed this important tool to the standards community," said David Iberson-Hurst, vice president of technical services for CDISC. "Tools like this will help increase the adoption of CDISC standards among sponsors and help FDA to continue to realize the many benefits of working with CDISC data standards."

"The free release of this tool underscores Phase Forward's longstanding commitment to industry standards," said Steve Rosenberg, senior vice president of products and services for Phase Forward. "As a founding sponsor of CDISC, we want to help ensure the widespread adoption of standards, making the submission process work more smoothly for everyone."

The DefineValidator tool is currently available for download at http://www.phaseforward.com/products/cdisc/.

About Phase Forward

Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. 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 290 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, SGS, Tibotec and the U.K. Medicines and Healthcare Products Regulatory Agency. Additional information about Phase Forward is available at www.phaseforward.com.

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, the performance and features of Phase Forward's products and services, the compliance of Phase Forward products and services with industry standards and regulatory requirements, demand for Phase Forward's products and services, 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, the possibility that the level of demand for Phase Forward's products and services may vary, change in industry and regulatory standards, and competition. 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.

SOURCE: Phase Forward

Phase Forward 
Elaine Maynard, 781-902-4371 
Elaine.maynard@phaseforward.com 
or 
CHEN PR, Inc. 
Randy Wambold, 781-672-3119 
rwambold@chenpr.com

Related terms: adoption, annual report, cancer, clinical, community, fda, healthcare, knowledge management, nasdaq, president, products, research, research and development, securities, standards, trial