eShowcase: WebSDM

August 1, 2007

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-08-01-2007, Volume 0, Issue 0

Hosted Service Offering Validates Data Prior to FDA Submission to Improve Review Process

Hosted Service Offering Validates Data Prior to FDA Submission to Improve Review Process

Phase Forward (Waltham, MA) announces a new submission checking service based on its Web Submission Data Manager (WebSDM) application. The hosted service offering produces a comprehensive report detailing all errors identified by WebSDM. Following the report, Phase Forward's CDISC specialists conduct an interactive review session using the customer's data and the same review capabilities that FDA uses.

WebSDM gives organizations a way to test FDA submissions for compliance with the CDISC Study Data Tabulation Model (SDTM) standard for human clinical trials. The Submission Checking System makes WebSDM data validation services broadly available as a hosted service, which enables organizations to quickly confirm if the data from trials conforms to SDTM standards to reduce possible delays from FDA data-related queries.

The service is available now, and current customers can convert to a license for ongoing studies.

Phase Forward, (781) 890-7878, www.phaseforward.com