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Veristat, ISI Choose Phase Forward WebSDM™
to Help Ensure Compliance with FDA Data Standards
Innovative CRO and Submissions Leader Rely on Application,
Co-Developed with the FDA, to Submit Clinical Trial Data with Confidence
Waltham, Mass.-January 29, 2009-Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced contract research organization (CRO) Veristat and submissions leader ISI have selected its Web Submission Data Manager (WebSDM™) application to help their clients submit CDISC SDTM-compliant data to the U.S. Food and Drug Administration (FDA). Phase Forward developed the WebSDM application in cooperation with the FDA, where it has been in use since 2004. Veristat’s and ISI’s adoption of the WebSDM software marks an expansion of the companies’ relationship with Phase Forward in response to client demand. Phase Forward has a longstanding commitment to ensuring its products are attractive to these industry segments. Many of its CRO clients, for example, utilize multiple Phase Forward products.
The emergence and acceptance of data standards in the life sciences industry has changed the way that organizations collect, format and submit clinical trial data to the FDA. The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) has become the preferred standard for companies submitting electronic data to the FDA and integrating clinical data sets from multiple sources. For CROs and other services firms that support the regulatory approval process, the need to efficiently exchange and review quality clinical trial data with their clients, and the improved speed and accuracy associated with electronic submission, is driving interest in the WebSDM product.
“We chose WebSDM knowing we will be working with an application that the FDA itself co-developed,” said Dr. John Balser, Veristat’s president and co-founder. “As a standard aimed at expediting the integration and analysis of clinical trial data by the FDA, SDTM is of paramount importance. WebSDM gives us confidence our clients’ submission files are compliant with SDTM.”
ISI’s core competencies include a focus on submitting regulatory-compliant global investigational and new marketing applications for the pharmaceutical and biotech industries. WebSDM enables ISI to help organizations prepare and deliver submissions with CDISC-compliant data as part of a submission, load SDTM-formatted study data, and check and correct errors and inconsistencies before they submit them to the FDA.
“When companies are preparing data for submission, correctly mapping data elements to the CDISC SDTM standard is critical,” said Paul Chung, executive vice president at ISI. “WebSDM becomes an important part of the ISI toolset to ensure that our clients are avoiding time-consuming and expensive regulatory approval delays due to inconsistencies in the data being submitted.”
CDISC developed SDTM as the result of an unprecedented collaboration among industry stakeholders and the FDA. The FDA adopted SDTM as an accepted format for electronic data capture (EDC) submissions in 2004. In December 2006, the FDA announced their intention to require SDTM as part of all electronic clinical data submissions.
“Phase Forward understands that CROs and submissions providers require innovative tools to help their clients optimize the process of submitting clinical trial data for FDA review,” said Dr. Mike Davies, Phase Forward vice president, Global CRO Partnerships. “Ensuring compliance with standards is a key component in this process. Partners like Veristat and ISI tell us they are choosing WebSDM for its use as a strategic asset in this regard.”
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 (InFormTM), phase I clinic automation (LabPasTM), clinical data management (ClintrialTM), clinical trials signal detection (CTSDTM), strategic pharmacovigilance (Empirica SignalTM) and Signal Management, adverse event reporting (Empirica TraceTM), applied data standards (WebSDMTM) and Web-integrated interactive voice response systems (ClarixTM). 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 280 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.