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Home : Products : Clinical Data Solutions : Applied Data Standards

Applied Data Standards

In today’s complex world of clinical research, biopharmaceutical and medical device companies, Contract Research Organizations and regulatory agencies are increasingly challenged by the inefficiencies of exchanging and reviewing quality clinical trial data. The emergence and acceptance of data standards in the life sciences industry has changed the way that companies collect, format and submit clinical trial data to the FDA. WebSDM gives organizations a means for testing FDA submissions for compliance and integrating clinical datasets from multiple sources.

The preferred standard for clinical trial data is the Clinical Data interchange Standards Consortium's (CDISC)_ Studay Data Tabulation Model (SDTM). The FDA eCTD (electronic Common Technical Document) specification indicates that a Define. XML is a required component which should be provided for all SDTM data submissions. The role of Define. XML plays in the submission is as a table of contents for the data ensuring that your Define .XML file completely and accurately reflects your SDTM data is critical. For organizations that do not already have an automated means of generating Define .xml documents, WebSDM provides an easy way to get started.

WebSDM™

The WebSDM application was developed under a Cooperative Research and Development Agreement between the FDA and Phase Forward’s Lincoln Safety Group, has been in use at the FDA since 2004 and is now commercially available to the clinical data management community. WebSDM allows users to load SDTM-format study data, 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. The WebSDM product allows companies to ensure submission files conform to the SDTM standard so that they can present them to regulatory agencies with confidence.

High-Impact Features and Functionality:

• 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