Phase Forward Announces WebSDM™ Release 3.0, with Support for CDISC Version 3.1.2 Standard
SAN DIEGO–(BUSINESS WIRE)–Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced the availability of WebSDM™ Release 3.0. The WebSDM tool 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.
With this release, the WebSDM product now includes support for checking data submitted in CDISC SDTM version 3.1.2 format. The product also includes updates to edit checks for earlier SDTM versions.
“We’re very pleased to see this new release of WebSDM 3.0 with SDTM 3.1.2 support,” said Charlie Willmer, senior director clinical systems, Purdue Pharma. “This will allow us to begin to capitalize on the features of SDTM v3.1.2, helping our partners provide us with more consistent data, and improving the efficiency of our regulatory submissions.”
Another important new feature of WebSDM 3.0 is the ability to generate a define.xml metadata description file in CDISC standard format. The define.xml file is used by the FDA to better understand the contents of CDISC submissions, and is necessary to load clinical study data into the FDA’s Janus data warehouse. The new WebSDM release features improved validation of define.xml files when provided, and when they are not provided, WebSDM will generate a file based on the contents of the study data it loads and validates. The new release also includes a wide variety of usability improvements.
“The new define.xml feature should be a boon to the many sponsors who have been struggling with the effort of creating define.xml files for their SDTM submissions,” said Sally Cassells, vice president of clinical systems and services, Phase Forward Lincoln Safety Group. “WebSDM makes the transition to this standard much easier and more reliable.”
Phase Forward will be showcasing its products including WebSDM at DIA’s 45th Annual Meeting in San Diego at booth #729.
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, Tibotec and the U.K. Medicines and Healthcare Products Regulatory Agency. Additional information about Phase Forward is available at www.phaseforward.com.
