
- Applied Clinical Trials-08-01-2007
- Volume 0
- Issue 0
eShowcase: WebSDM
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,
Articles in this issue
about 18 years ago
New Policies to Increase Information on Trialsabout 18 years ago
Laying with the Lionsabout 18 years ago
From Cradle to Graveabout 18 years ago
Software Decisions and Opportunity Costsabout 18 years ago
Sponsors: PAY HEEDabout 18 years ago
Preparing for Europe's Pediatric Rulesabout 18 years ago
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