Data Standardization

The clinical data standardization team at TAKE can help convert datasets, utilizing an internal technology framework. SDTM mapping tools are used to ensure that the mapping specifications are defined accurately and case report forms are annotated aptly. The resulting package includes Converted SDTM Datasets, DEFINE package, SDTM annotated CRFs and a Reviewer’s guide.

Business Need

• Existence of regulations requiring submissions of legacy studies in SDTM format
• Management of clinical data warehouses based on loading standards
• Requirement for sharing of datasets between drug development partners in SDTM format

How TAKE Can Help You

TAKE’s cost-effective Data Standardization services address all or individual elements of SDTM conversion including annotation, creating mapping specifications for all SDTM domains, conversion programming, QC steps, validating for published WebSDM and Janus checks, creating DEFINE package and Reviewer’s guide.

Our Services

Consulting for CDISC transformation Implementation strategy Readiness/Capability assessments QC review of final SDTM submission Infrequent / Frequent ad-hoc hourly consulting Defined role within the sponsor project team Customized SDTM guidance
Data Standardization SDTM Conversion CRF Annotation with SDTM variables SDTM Mapping SDTM Conversion programming Legacy or ongoing studies SDTM compliance check and validation Define.xml or Define.pdf SDTM-based data pooling to support integrated summaries (ISS/ISE) ADaM Implementation Clinical systems development and integration Clinical Data Warehousing