Our CDISC Services ensure clinical trial data is standardized, compliant, and submission-ready through expert SDTM and ADaM implementation. We provide end-to-end support for CRF annotation, SDTM mapping, ADaM dataset creation, Define-XML, validation, and regulatory submission packages. Our experienced programming team delivers high-quality, traceable datasets that meet global regulatory expectations, enabling efficient statistical analysis and faster submissions to agencies such as the FDA and PMDA.
Implementation of CDISC SDTM standards, including CRF annotation, SDTM mapping, domain creation, metadata development, and submission-ready datasets that comply with regulatory requirements.
Development of analysis-ready ADaM datasets with complete traceability from SDTM, supporting statistical analyses, Tables, Listings & Figures (TLFs), and Clinical Study Reports (CSRs).
Comprehensive validation of SDTM and ADaM datasets using industry-standard tools such as Pinnacle 21, ensuring CDISC compliance, data consistency, and audit readiness.
Preparation of complete submission packages including Define.xml, Reviewer Guides, annotated CRFs, metadata documentation, and eCTD-compliant deliverables for global regulatory submissions.
Rigorous quality assurance processes, independent validation, and double-programming reviews to ensure accurate, traceable, and high-quality datasets that meet regulatory expectations.