Waltham, Massachusetts – (The Hosting News) – June 25, 2007 – Web host and integrated data management solutions firm, Phase Forward Incorporated, has debuted a new hosted submission checking service offering designed to assist customers in submitting CDISC standards-compliant data to the FDA.
The new WebSDM hosted service solution, was developed to enable customers to validate clinical trial data, prior to submission to the FDA Information Association 43rd Annual Meeting. 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.
Wayne Kubick, Senior Vice President at Phase Forward Lincoln Technologies safety division remarked, ”A successful FDA submission represents the culmination of years of hard work on the part of our customers and partners. 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’s) product, which is built on the platform.
Phase Forward is a provider of web hosting and 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 260 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, Food and Drug Administration, GlaxoSmithKline, Merck, U.K. Medicines and Healthcare Products Regulatory Agency, National Institutes of Health, Procter and Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Serono and Servier.
To learn more, please visit: www.phaseforward.com.