Phase Forward Delivers Next Generation Clinical Trial Data Collaboration, Analysis and Submission-Ready Functionality.PHILADELPHIA -- New WebSDM(TM) Version, Available Immediately, Enables Clinical Trial Data Managers to Prepare and Share Submission-Ready CDISC CDISC Clinical Data Interchange Standards Consortium SDTM SDTM Study Data Tabulation Model SDTM Straight Down the Middle (pinball wizard terminology) Clinical Data Files 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 immediate availability of a new version (1.5) of the Web Submission Data Manager (WebSDM(TM)) product. WebSDM(TM) is an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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. This 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 XML in full Extensible Markup Language. Markup language developed to be a simplified and more structural version of SGML. It incorporates features of HTML (e.g., hypertext linking), but is designed to overcome some of HTML's limitations. support and improved validation and edit checking Same as validity 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 according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. Senior Research Analyst Chris Connor Chris Connor (born 8 November 1927, Kansas City, Missouri) is a jazz singer known for her distinctive style and expression. Her father was an eminent musician and Connor soon studied and became proficient in the clarinet. 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(TM) EDC EDC See: Export Development Corp. functionality and the 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) Clinical Trials Signal Detection environment, WebSDM is part of a comprehensive solution for clinical data capture, reporting, analysis, submission and safety signal detection. "Today's announcement further reflects our commitment to CDISC standards as an integral part of our overall product strategy," said Bob Weiler, president and chief executive officer, Phase Forward. "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 is fully integrated 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 The Pennsylvania Convention Center is a multi-use public facility in Philadelphia, Pennsylvania which is designed to accommodate conventions, exhibitions, conferences and other events. in Philadelphia. 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. 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(TM)), strategic pharmacovigilance (WebVDME(TM) and Signal Management), adverse event reporting (Clintrace(TM)) 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 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 and Serono. 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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, the ability of Phase Forward's customers to realize benefits from the use of these products and services, and continued compatibility with industry standards. 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, changes in commonly used industry standards and regulations, and the possibility that customers' needs or plans may change over time. 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 Form 10-Q See 10-Q. . |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion