Phase Forward Becomes CDISC Registered Solution Provider.WALTHAM, Mass. -- 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 that it has obtained Registered CDISC CDISC Clinical Data Interchange Standards Consortium Solution Provider (RCSP RCSP Rufous-Crowned Sparrow (Aimophila ruficeps bird species) RCSP Remote Call Service Position RCSP Radar Calibration Spheres Project RCSP Radar Control & Status Panel RCSP Rate Controlled Static Priority ) status from the Clinical Data Interchange Standards Consortium Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization, whose mission is "to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of (CDISC) for supporting the organization's standards throughout its product suite and service offerings. CDISC is widely embraced by regulatory agencies, technology providers, and drug companies as critical to developing software tools and services around standards which provide for the flexible exchange of clinical information necessary for drug development and approval. As one of a select number of electronic data capture (EDC EDC See: Export Development Corp. ) vendors acknowledged as an RCSP, and a long-time member of CDISC, Phase Forward offers the widest range of CDISC registered products to customers who are seeking improved efficiency in their clinical data management process. By obtaining certification for three unique clinical data standards, Phase Forward has affirmed its industry leadership by providing independently reviewed solutions designed to meet the highest standards in the clinical data management industry. The mission of CDISC is to develop and support global, platform-independent data standards that facilitate system interoperability to improve medical research and related areas of healthcare. CDISC promotes standards consisting of data-model components designed to support data flow in clinical trials, the goal of which is greater process efficiency across clinical applications. Clinical data standards also drive interoperability so that clinical research data files and support information can be transported and shared among multiple groups independent of the platform on which it resides. Phase Forward's product suite is now certified as supporting three separate CDISC data models, including: --Study Data Tabulations Model (SDTM SDTM Study Data Tabulation Model SDTM Straight Down the Middle (pinball wizard terminology) ), as supported by its Clintrial(TM) clinical data management and Clinical Integration Solution products; --Laboratory Standards Team model (LAB), as supported through its Clintrial Lab Loader product; and, --Operational Data Modeling (ODM (Original Design Manufacturer) A contract manufacturer that uses its own designs and intellectual property (IP). See contract manufacturer. ), as supported by the company's client consulting services. A long-term member of the CDISC consortium, Phase Forward was recognized for adhering to the CDISC Code of Ethics Code of Ethics can refer to:
--Incorporation of the CDISC Study Data Tabulation tab·u·late tr.v. tab·u·lat·ed, tab·u·lat·ing, tab·u·lates 1. To arrange in tabular form; condense and list. 2. To cut or form with a plane surface. adj. Having a plane surface. Model (SDTM) and Laboratory Standards Team (LAB) with its Clintrial clinical data management solution including a tool within Lab Loader for mapping LAB files into SDTM; --Conducting CDISC workshops for users of Clintrial; --Providing support for CDISC in Japan, for in-country users of its products; --Serving as the first company to attempt an E2B - SDTM mapping (Serious Adverse Event capture in EDC and transfer to safety database); and, --Liaison with the NHS, the UK health service, regarding Health Level 7 (HL7) standard in medical records, and planning for future data transfer. "Phase Forward's mission is to provide solutions that help our customers bring their drugs and therapies to market with greater efficiency and safety," remarked Bob Weiler, president and chief executive officer of Phase Forward. "CDISC certification recognizes that we are building our products on a foundation based on industry standards. I believe this underscores our ability to provide market-ready solutions that offer flexibility for clinical data management and safety, with well-designed interoperability so that our clients can meet their current and future needs." 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 in electronic data capture (EDC), clinical data management (CDM), and adverse event reporting (AER) to help pharmaceutical, biotechnology, and medical device companies bring needed drugs and therapies to market faster and more safely. Lincoln Technologies, acquired by Phase Forward in August of 2005, delivers solutions for pharmacovigilance, data standardization, and safety signal detection. The combined companies' products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 220 organizations and regulatory agencies worldwide including: AstraZeneca, Biogen Idec, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, 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. , GlaxoSmithKline, Guidant, MHRA MHRA Medicines and Healthcare Products Regulatory Agency MHRA Modern Humanities Research Association (United Kingdom) MHRA Minnesota Human Rights Act MHRA Malta Hotels and Restaurants Association , NIH "Not invented here." See digispeak. NIH - The United States 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. |
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