CDISC & Data Standards
CDISC Development, Migration & Submission Support
Submission-ready CDISC data from raw or legacy sources, built for traceability, conformance and regulatory review.
Novastatix supports sponsors and CROs across the full CDISC lifecycle — SDTM and ADaM development, legacy-data migration, standards conversion, submission metadata, Pinnacle 21 validation and remediation, and submission-ready study-data packages for global regulatory submissions.
Our services support new clinical studies, legacy-study conversions, standards upgrades, integrated submission programs and regulatory study-data requirements.
SDTM Development & Legacy Migration
SDTM development, mapping, legacy conversion and standards remediation.
- SDTM dataset development from raw clinical data
- Legacy-data conversion to applicable SDTM standards
- Study-specific SDTM mapping specifications
- Domain mapping and derivation implementation
- Supplemental qualifiers and custom-domain assessment, where applicable
- Controlled terminology mapping and harmonization
- Remediation and standards-version upgrade of existing SDTM datasets, where required
ADaM Development & Traceability
Analysis-ready ADaM development with end-to-end traceability.
- Analysis Data Model (ADaM) dataset development
- Analysis-ready datasets traceable to SDTM and source data
- ADaM specifications and derivation documentation
- Analysis populations, flags, parameters and endpoint derivations
- End-to-end traceability from source data through SDTM and ADaM to statistical outputs
- Integrated ADaM datasets supporting Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE)
- Legacy analysis-data conversion to ADaM, where applicable
Metadata & Submission Documentation
Submission metadata and reviewer documentation synchronized with final datasets.
- Annotated Case Report Form (aCRF) development
- Define-XML for SDTM and ADaM
- Dataset-, variable- and value-level metadata
- Computational-method and derivation documentation
- Study Data Reviewer's Guide (SDRG)
- Analysis Data Reviewer's Guide (ADRG)
- Metadata consistency and completeness review
- Submission documentation synchronized with final datasets
CDISC Validation & Remediation
Pinnacle 21 validation, remediation, QC and submission-readiness review.
- Pinnacle 21 validation and conformance review
- Review, classification and remediation of validation findings
- Documentation and justification of unresolved findings, where appropriate
- Controlled terminology and standards-compliance review
- Cross-dataset and metadata consistency checks
- Independent QC of SDTM, ADaM and submission metadata
- Re-validation and final submission-readiness assessment
- Independent review of existing CDISC data packages, where requested
Standards Consulting & Cross-Study Harmonization
Implementation strategy, standards governance and cross-study harmonization.
- CDISC implementation and migration strategy
- Legacy-study assessment and migration planning
- Sponsor-specific standards and implementation conventions
- Standards-version impact assessment and upgrade planning
- Standards library and reusable metadata development
- Cross-study harmonization of SDTM, ADaM, metadata and controlled terminology
- Standards alignment across studies supporting integrated analysis and submission programs
Global Submission Data Support
Submission-ready study-data packages and regulatory follow-up support.
- Submission-ready CDISC study-data packages supporting global regulatory submissions
- Support aligned with applicable requirements for FDA, Health Canada, EMA, MHRA, PMDA and other regulatory authorities
- XPT transport-file preparation, naming conventions and submission folder structure
- Technical conformance, QC and submission-readiness review of datasets and supporting documentation
- Support for integrated submission data packages, where applicable
- Supplemental datasets and documentation requested during regulatory review
- Responses to regulatory authority questions relating to submitted study data
- Dataset remediation, re-validation and updated submission packages following regulatory feedback