Overview of CDISC
The Clinical Data Interchange Standards Consortium (CDISC) provides a unified framework for organizing, analyzing, and submitting clinical research data. Our experts guide organizations through understanding CDISC’s foundational models — SDTM, ADaM, CDASH, Define.xml, and Controlled Terminologies — and their critical role in ensuring data transparency, traceability, and regulatory acceptance.
Key Focus Areas:
Understanding CDISC models and standards
Mapping legacy datasets to CDISC structures
Optimizing data for regulatory submissions
Data Standards Governance
Establishment of organization-wide CDISC frameworks Creation of standard metadata repositories (libraries, templates, macros) Maintenance and version control of controlled terminologies (CT) Training and documentation for internal data governance teams
SDTM (Study Data Tabulation Model) Development
Mapping raw data to SDTM domains (DM, AE, EX, VS, LB, etc.) Review of annotated CRFs and data specifications Creation of Define.xml (v2.0) and Reviewer’s Guide QC and validation of SDTM datasets
ADaM (Analysis Data Model) Development
Derivation of analysis-ready datasets for efficacy and safety Compliance with ADaM IG (Implementation Guide) standards Traceability from SDTM to analysis results Validation and statistical review of ADaM datasets
Regulatory Submission Support
Preparation of FDA eSubmission packages Compliance checks with FDA Technical Conformance Guides Define.xml, Reviewer’s Guide, and Metadata documentation End-to-end submission readiness audits
CDISC Training & Workshops
Corporate and team-level CDISC awareness programs Hands-on workshops on SDTM, ADaM, and Define.xml creation Case-based learning from real-world clinical submissions
Our Expertise
Experienced Biostatisticians & CDISC Programmers Certified SAS and CDISC Professionals Deep understanding of regulatory frameworks (FDA, PMDA, EMA) Proven record in NDA/BLA submissions
Tools & Technologies
SAS Base, SAS Clinical Data Integration (CDI) Pinnacle 21 Enterprise / OpenCDISC Validator Define.xml Editor, ODM Tools R, Python (for automation and validation support)