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Phase Forward Announces New Hosted Submission Checking Service Offering to Help Customers Submit CDISC Standards-Compliant Data to FDA

Posted on: Monday, 18 June 2007, 09:02 CDT

Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced a new Submission Checking Service offering based on its Web Submission Data Manager (WebSDM™) application. Developed under a Cooperative Research and Development Agreement between the FDA and Phase Forward's Lincoln Technologies safety division, WebSDM gives organizations a means for testing FDA submissions for compliance with the Clinical Data Interchange Standards Consortium's (CDISC) Study Data Tabulation Model (SDTM) standard for human clinical trials.

The Submission Checking Service makes WebSDM data validation services broadly available as a hosted service offering, with a rapid contracting and access process that conforms to the tight schedules of manufacturers who are preparing applications for marketing approval with the FDA. The service enables organizations to easily confirm that data from trials conform to the SDTM standard, so that they can decrease the likelihood of delays caused by FDA data-related queries and submissions that are returned because of data discrepancies or inconsistencies.

"A successful FDA submission represents the culmination of years of hard work on the part of our customers and partners," said Wayne Kubick, senior vice president, Phase Forward Lincoln Technologies safety division. "Many of our customers have told us that WebSDM has been extremely helpful to their submission process by verifying the quality and compliant structure of their data before it's sent to FDA. Our hosted submission checking service should make it possible for a broader group of customers to benefit in a timely, cost-effective manner."

As one of the FDA's Critical Path initiatives to improve the efficiency of data review and to populate the planned Janus data warehouse, the agency has requested that submitted tabulation data conform to the CDISC SDTM Implementation Guide for Human Clinical Trials specification. SDTM data submissions are validated with WebSDM by the FDA's Office of Business Process Support (OBPS), but their primary responsibility is to support the FDA review divisions, rather than support sponsors regarding data issues.

Significant errors in data conformance or consistency can delay or inhibit the review process, resulting in extra uncertainty and effort on the part of the FDA, as well as increased costs to the sponsor. If difficulties with data result in an FDA request to correct data deficiencies, the impact to the sponsor can be particularly pronounced. It is therefore in the interest of both the FDA and study sponsors to ensure before submission that data is sufficiently compliant and consistent to facilitate the FDA review process. This reduces the risk of uncovering data issues that require research, analysis, delay and corrective action on both sides.

The hosted service offering produces a comprehensive report detailing all errors identified by WebSDM. Phase Forward CDISC specialists then conduct a two-hour interactive review session using the customer's own data to discuss identified errors, leveraging the same advanced reporting, visualization and review capabilities within WebSDM that are already available to FDA reviewers. This allows the manufacturer to examine data in the same environment FDA reviewers will use. The service also includes full customer access to the hosted data using the WebSDM error management and review tools for a 15-day period.

The hosted WebSDM Submission Checking Service is available immediately. WebSDM Submission Checking Service customers have the option of converting to a full WebSDM license for ongoing studies, and of accessing the capabilities of Phase Forward's Clinical Trials Signal Detection (CTSD™) product, which is built on the platform.

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™), 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 250 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, the U.S. Food and Drug Administration, or FDA, GlaxoSmithKline, Harvard Clinical Research Institute, Merck & Co., Merck Serono, Novartis, Novo Nordisk, PAREXEL International, Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Tibotec, the U.K. Medicines and Healthcare Products Regulatory Agency and Servier. Additional information about Phase Forward is available at www.phaseforward.com.

Cautionary Statement

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 provisions of the Private Securities Litigation Reform Act of 1995. This press release contains express or implied forward-looking statements relating to, among other things, the performance and acceptance of Phase Forward's products, the use of Phase Forward products by customers that include governmental agencies, and the benefits to customers from the use of such products. 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, Phase Forward's inability to convince current and potential customers to order its products, the failure of customers to realize benefits from the use of these products, changes in industry standards, and changes in regulatory requirements applicable to Phase Forward's customers and the manner in which they conduct business, changes in the methods and systems used by governmental agencies to evaluate clinical data submissions. 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.

Source: Business Wire

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