CDISC Data Standards Implementation

Standardizing your clinical trial data facilitates regulatory submissions and compliance with reporting requirements

Data standards are crucial in clinical studies to contribute to the overall success of the clinical study and are essential to ensure consistency, quality, and efficiency of clinical study data across different studies and datasets. Adhering to standardized data formats and terminologies facilitates efficient data collection from EDC or CRFs, data management, statistical analysis, study reporting, and supports data integration and ensures compliance, regulatory requirements, and expectations. 

Does your team have the expertise and bandwidth to standardize your clinical trial data?   Let's Talk.

Currently - the FDA (US), PMDA (Japan) and NMPA (China) - all require that your clinical trial data be submitted in compliance with CDISC data standards.  Are you ready?

Data Standards Services 

At Veristat, as a part of CDISC Standards (Clinical Data Interchange Standards Consortium),our Statistical Programmingexperts create the following domains, datasets, and define.xml: 

  • Study Data Tabulation Model (SDTM) domains, standardized variables using controlled terminology 
  • Analysis Data Model (ADaM) datasets, standardized variables using controlled terminology 
  • Controlled Terminology used (e.g., SDTMIG Terminology, ADaMIG Terminology, etc.) 
  • Clinical Data Acquisition Standards Harmonization (CDASH) CRF domain, standardized variables using controlled terminology when EDC is built at Veristat 
  • Define.xml for SDTM and ADaM datasets and controlled terminology used in the study 
  • Reviewers Guides for SDTM and ADaM datasets 
  • Regulatory submission-ready package development 
Not sure where to begin with standardizing your clinical trial data?


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