Statistical Programming

Metadata-driven SDTM/ADaM development, TLF automation, and validated submission packages.

Standards-First Programming for Review-Ready Outputs

Magnus CRO delivers reproducible pipelines for clinical data transformation and analysis. Our programmers work shoulder-to-shoulder with biostatistics and data management to ensure traceability from raw data to regulatory deliverables.

SDTM Development

Study-level SDTM specifications, annotated CRFs, controlled terminology, and mapping rules.
Programmatic derivations for complex domains (AE, EX, LB, QS, PK, TU/RS).
Pinnacle 21 conformance, issue resolution, reviewer guide (SDRG) preparation.

ADaM & Analysis Data

ADSL, ADAE, and endpoint-specific ADaM datasets aligned to SAP and estimands.
Derivations for time-to-event, repeated measures, composite endpoints, and responder analyses.
Traceability from SDTM to ADaM with clear algorithms and variable-level metadata.

TLF Generation & Automation

Highly formatted Tables, Listings, and Figures (R/SAS) aligned to SAP shells.
Reusable macro libraries, parameterized programs, and metadata-driven pipelines.
Automated pagination, footnotes, significance markers, and style guides for consistency.

Validation & Quality

Independent double programming or review for critical datasets and outputs.
Unit tests, metadata checks, and reproducibility audits under version control.
Comprehensive issue logs with resolution details and impact assessments.

Submission Package

Define-XML (SDTM & ADaM), Study Data Reviewer’s Guides (SDRG/ADRG).
Program packages, logs, and ARM (Analysis Results Metadata) where requested.
Responses to regulatory information requests with targeted re-runs and clarifications.

Need SDTM/ADaM and TLFs You Can Trust?

Partner with Magnus CRO to build robust, validated analysis pipelines and submission-ready packages.

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