Data standards are crucial to the overall success of clinical studies 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.
With the FDA, PMDA, and NMPA all requiring CDISC compliance, is your data standardization strategy where it needs to be?
CDISC Compliance Isn't Optional For Most Major Markets.
The FDA and PMDA require your clinical trial data to meet CDISC standards before they'll even begin reviewing your submission, regardless of how strong the underlying science is, and NMPA strongly recommends it as well, with adoption expected to tighten further.
Our statistical programming experts build every piece that compliance requires: SDTM and ADaM datasets with standardized variables and controlled terminology, CDASH-aligned CRFs when your EDC is built at Veristat, Define.xml documentation, and the Reviewer's Guides that help agency reviewers navigate your submission package, all the way through to a complete, regulatory submission-ready package.
Veristat's Offerings
Veristat Expertise in Strategic Consulting
Standards from the inside, not just compliance from the outside.
As a CDISC (Clinical Data Interchange Standards Consortium) member organization, our statistical programming experts stay close to how these standards evolve, not just how to follow them.
Built-in Expertise when we build your EDC.
When your EDC is built at Veristat, CDASH-aligned CRF domains and controlled terminology are designed in from the start, not retrofitted later.
Standards that carry through to submission.
Our approach considers how standardized data will be used downstream, from statistical analysis and reporting through regulatory review. By aligning SDTM, ADaM, controlled terminology, Define.xml, and Reviewer’s Guides, we create consistency across the data package and give reviewers the context they need to navigate the evidence efficiently.
Our Expertise in Data Standards
290+
CDISC-compliant analysis datasets (SDTM/ADaM) developed over the past 5 years.
Veristat's Offerings
Data Standards and Submission Services
SDTM Domains.
Development of Study Data Tabulation Model (SDTM) domains in accordance with applicable standards and controlled terminology
ADaM Datasets.
Development of Analysis Data Model (ADaM) datasets in accordance with applicable standards and controlled terminology
CDASH CRF Domains.
Development of Clinical Data Acquisition Standards Harmonization (CDASH) domains when the EDC is built by Veristat
Controlled Terminology.
Application of standardized controlled terminology across SDTM, ADaM, and applicable CDASH deliverables.
Define.xml Development.
Development of Define.xml documentation for SDTM and ADaM datasets, including applicable study metadata and controlled terminology
Reviewer’s Guides.
Development of the Clinical Study Data Reviewer’s Guide (cSDRG) for SDTM and the Analysis Data Reviewer’s Guide (ADRG) for ADaM.
Regulatory Submission Ready Package.
Completion of the complete data package and associated documentation for regulatory submission.
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Give your data a structure that moves it forward.
Data standards do more than satisfy regulatory requirements. Veristat transforms clinical trial data into consistent, submission-ready formats that can move cleanly into analysis, interpretation, and regulatory review—so the evidence behind your program is ready to inform the decisions ahead.
The FDA and PMDA (Japan) require clinical trial data to be submitted in compliance with CDISC data standards. NMPA (China) strongly recommends CDISC compliance as well, with adoption expected to tighten further.
Yes. Veristat develops Define.xml for both SDTM and ADaM datasets, along with the controlled terminology used throughout the study.
CDASH CRF domain standardization is provided when the EDC is built at Veristat. Programs using a different EDC vendor should confirm CDASH alignment directly with that provider.
