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Data Warehousing
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Our data warehousing process allows data from many disparate sources and study protocols to be mapped into a standardized format so that data from all protocols can be stored, easily retrieved, validated and subsequently analyzed. Data from vendor-based systems (e.g., hospital information systems) and from research databases can be mapped into several domains based on the CDISC Study Data Tabulation model (SDTM).1

DM-Encompass contains three components:
  • Mapping: Allows data to be mapped from an existing format into the CDISC SDTM using data driven technology.
  • Coding: Allows data from open response fields and items that require coding or standardization (e.g., labs, clinical events, medications) to be coded using standardized dictionaries (e.g., MedDRA, WHO Drug).
  • Reporting: Allow the user to access validation reports (e.g., out of range or inconsistent values) and descriptive statistics for each SDTM domain and across domains.
1 Ref: Study Data Tabulation Model, Version 1.2, 11/12/2008 Clinical Data Interchange Standards Consortium, Inc. and Ref: Study Data Tabulation Model Implementation Guide: Human Clinical Trials, Version 3.1.2, 11/12/2008 Clinical Data Interchange Standards Consortium, Inc.