Phase Forward Announces Release of Free Tool to Streamline FDA Submissions
October 19 2009 - 11:45AM
Business Wire
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™ 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.
Phase Forward (NASDAQ:PFWD)
Historical Stock Chart
From Jun 2024 to Jul 2024
Phase Forward (NASDAQ:PFWD)
Historical Stock Chart
From Jul 2023 to Jul 2024