Oracle Health Sciences WebSDM On Demand

Oracle Health Sciences WebSDM enables organizations to test FDA submissions for compliance and integrate clinical research datasets from multiple sources. Developed under a cooperative research and development agreement between the FDA and Phase Forward (acquired by Oracle in 2010), the Oracle Health Sciences Web SDM application has been in use at the FDA since 2004.

The software allows users to load clinical study data in the Clinical Data Interchange Standards Consortium’s Study Data Tabulation Model (SDTM) format, check and correct errors and inconsistencies, and browse data in a variety of tabular and graphical formats. Users may browse studies one at a time or perform pooling of data across studies for combined analysis. Oracle Health Sciences WebSDM allows companies to ensure submission files conform to the SDTM standard so that they can present them to regulatory agencies with confidence.

BENEFITS

  • Provides error and data consistency checking to verify conformance with the SDTM implementation guides
  • Generates Define.xml files
  • Features natural language error messages and filter-and-sort capabilities for error review
  • Enables drill down to rule definition and error records with annotation capabilities
  • Provides data browsing with graphical display tools in a Web-based user interface
  • Identifies record relationships and comments
  • Features custom and predefined reports
  • Provides cross-study reporting
  • Allows exchange of custom report definitions and results with FDA reviewers to resolve queries
  • Supports all current CDISC SDTM 3.1.2 and prior versions
  • Supports Define.XML metadata import
  • Integrates with Patient Profiles, SAS and Microsoft Excel
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