Data Standards Implementation – ADaM

Comprehensive Clinical Data Conversion Services to CDISC ADaM Data Standards

Implementing CDISC ADaM Data Standards is our industry’s best practice and is also an FDA requirement for NDAs and BLAs.

Data standardization provides a consistent general framework for organizing study data in regulatory submissions that are easily interpreted, understood, and navigated by regulatory reviewers.

Data standardization thus improves the overall presentation of data and efficiency of review.

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ALMUSTAT , AN EXPERIENCED CDISC SOLUTIONS PROVIDER ENSURING YOUR CLINICAL DATA ARE READY FOR SUBMISSION

Production of ADaM Datasets
- Creation of dataset specification file
- define.xml and define.pdf file creation from ADaM dataset definitions
- Electronic validation of CDISC compliance to ADaM standards
- Creation of integrated ADaM datasets for Integrated Summaries of Safety & Efficacy (ISS/ISE)

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CDISC Standards:
- Submitted to regulatory in addition to SDTM: The need for transparency (traceability) is the fundamental principle of ADaM.
- Study Data Tabulations (SDTM): datasets containing data collected during the study and organized by clinical domain.
- Analysis Data Model (ADaM): datasets incorporate derived and collected data into one dataset designed for statistical analysis (“one proc away” principle).

Data Standards Implementation – ADaM

Comprehensive Clinical Data Conversion Services to CDISC ADaM Data Standards

ALMUSTAT , AN EXPERIENCED CDISC SOLUTIONS PROVIDER ENSURING YOUR CLINICAL DATA ARE READY FOR SUBMISSION

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