Statistical Programming
Regulatory-Ready Datasets and Analyses Built for Submission Success
SCiAN’s Statistical Programming team delivers high-quality, CDISC-compliant datasets and analysis outputs that support clinical development, regulatory submissions, and informed decision-making. Working seamlessly with our Clinical Data Management and Biostatistics teams, we transform clinical data into standardized, traceable, and submission-ready deliverables that meet global regulatory expectations.
From early-phase studies through pivotal trials and submissions, we provide scalable programming solutions tailored to each sponsor’s needs while maintaining the highest standards of quality, consistency, and compliance.
SDTM Development
We develop fully compliant Study Data Tabulation Model (SDTM) datasets that support regulatory submissions and facilitate efficient regulatory review.
Services include:
- SDTM specification development
- SDTM mapping and implementation
- Controlled terminology management
- Define.xml generation
- Pinnacle 21 validation and issue resolution
- Submission package support
ADaM Development
Our programmers create Analysis Data Model (ADaM) datasets designed to provide complete traceability from source data through statistical analyses.
Services include:
- ADaM specification development
- Analysis dataset programming
- Derived endpoint creation
- Traceability documentation
- Validation programming
- Regulatory submission readiness
Tables, Listings and Figures (TLFs)
We produce accurate, reproducible, and publication-quality outputs that support clinical study reporting and regulatory submissions.
Services include:
- TLF shell development
- CSR tables and listings
- Safety analyses
- Efficacy analyses
- Interim analysis outputs
- Integrated summaries and pooled analyses
Submission Support
Our team has extensive experience supporting regulatory submissions across multiple regions and therapeutic areas.
Services include:
- FDA-compliant submission packages
- Electronic submission support
- Reviewer guide development
- Data standards compliance review
- Submission quality control
- Regulatory response support
Why SCiAN?
- Deep expertise in CDISC standards and implementation
- Extensive experience across Phase I–IV clinical studies
- Integrated collaboration with Data Management and Biostatistics teams
- Robust quality control and validation processes
- Flexible resourcing models for studies of any size
- Proven support for programs advancing through acquisition, partnership, and regulatory submission