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Clinical Trials: SDTM and ADaM

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The CDISC CDASH standard for collection and common nomenclature for clinical trials data, the Study Data Tabulation (SDTM), and Analysis Data (ADaM) models are the accepted standards for clinical trials data. Summit Analytical are experts in the efficient development and validation of CDISC compliant, fully documented, submission ready, SDTM and ADaM datasets. As part of our Regulatory Data Standards and Compliance services for each study we will provide our clients with submission ready:

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SDTM specifications and Annotated CRF

SDTM specifications and Annotated CRF

SDTM Define.xml and Study Data Reviewer’s Guide (SDRG)

ADaM specifications

ADaM specifications

ADaM datasets, linked to the planned analyses

ADaM Define.xml and Analysis Data Reviewer’s Guide (ADRG)

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