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Products : HPR : CDS : Applied Data Standards
Applied Data Standards
In today’s complex world of clinical research, biopharmaceutical and medical device companies, CROs 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. CDISC SDTM-compliant clinical trial data is increasingly becoming the preferred standard for companies facing the challenge of submitting data electronically to the FDA and integrating clinical datasets from multiple sources.
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ADS Solution: netSDTM™
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The web-based Submission Data Trial Manager (netSDTM) application 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 netSDM 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
· 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 versions
· Supports Define.XML metadata import
· Integrates with Patient Profiles, SAS and Microsoft® Excel
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