Las Vegas, Nevada – (The Hosting News) – July 18, 2006 – Data management solutions firm, Phase Forward, has launched a new version (1.5) of its Web Submission Data Manager product. WebSDM is an FDA submission review tool that was originally developed by Lincoln Technologies in collaboration with the FDA, and first made available to the industry in the fall of 2005.
The latest release incorporates the newest Clinical Data Interchange Standards Consortium’s (CDISC) Study Data Tabulations Model (SDTM) standard, version 3.1.1., as well as enhanced Define.XML support and improved validation and edit checking functions. This powerful data review solution streamlines operations with submission-ready files for clinical trial data.
WebSDM 1.5 represents a strategic implementation of the CDISC standard for clinical trial data, illustrating Phase Forward’s commitment to industry standards. According to Senior Research Analyst Chris Connor at Health Industry Insights, an IDC Company, ”Biopharmaceutical companies that implement CDISC early will see the benefits of interoperability standards in future data integration projects.”
In combination with Phase Forward’s InForm EDC functionality and the CTSD Clinical Trials Signal Detection environment, WebSDM is part of a comprehensive solution for clinical data capture, reporting, analysis, submission and safety signal detection.
Bob Weiler, President and Chief Executive Officer of Phase Forward explained, ”Today’s announcement further reflects our commitment to CDISC standards as an integral part of our overall product strategy. Our goal is to help customers adopt clinical data standards as part of their clinical data management, analysis and safety evaluation cycle.”
WebSDM’s core functionality allows users to load and validate CDISC SDTM-formatted clinical trial data files, browse them using standard views, access and analyze Patient Profiles, and prepare files for regulatory submission. The product’s enhanced enterprise capabilities deliver next generation collaboration and data sharing between stakeholders throughout the clinical development process, addressing the needs of manufacturers, clinical research organizations (CROs), affiliates and regulatory reviewers.
The new features of the WebSDM 1.5 application include:
— Implementation of CDISC SDTM version 3.1.1
— Support for Define.XML
— Added functionality for validation checking
— Improved support for customer-defined SDTM edit check rules
— Enhanced user administration tools that enable more efficient user account management
— Enhanced remote collaboration capabilities that make it possible to run WebSDM over the Internet with no client footprint
WebSDM was designed to be fully integratable with CTSD, which allows advanced screening for potential safety signals in clinical trial data, using the same interface and SDTM files as WebSDM. This new integration capability will be showcased at Phase Forward’s booth #1427 at the 42nd Annual Meeting of the Drug Information Association (DIA), taking place this week (June 18-22) at the Pennsylvania Convention Center in Philadelphia.
Phase Forward is a provider of integrated data management solutions for clinical trials and drug safety. The company offers solutions for electronic data capture (InForm), clinical data management (Clintrial), clinical trials signal detection (CTSD), strategic pharmacovigilance (WebVDME) and Signal Management), adverse event reporting (Clintrace) and applied data standards (WebSDM). 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 230 organizations and regulatory agencies worldwide including: AstraZeneca, Biogen Idec, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, Food and Drug Administration, GlaxoSmithKline, Guidant, Merck, U.K. Medicines and Healthcare Products Regulatory Agency, National Institutes of Health, Procter and Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute and Serono.
WebSDM 1.5 is available immediately in a variety of licensing options, including pilot programs, hosted environments and enterprise installations. For more details on WebSDM 1.5, visit: www.phaseforward.com.
Additional information about Phase Forward is available at www.phaseforward.com.