Clinical SAS Programming
Regulatory-Grade, Trial-Tested
CDISC-compliant SAS programming across the full trial data lifecycle — from protocol-to-SAP alignment and SDTM/ADaM dataset creation through TLF production and FDA/EMA eCTD submission packages.
Statistical Programming That Regulators Trust
Clinical trials live and die by data integrity. A single deviation from CDISC specifications in a regulatory submission can trigger an FDA Complete Response Letter — adding months and millions to a drug's path to market. SWA's clinical SAS team brings the precision required to navigate that environment without the delays that typically come with it.
Our biostatistical programmers have supported Phase I through Phase IV studies across oncology, cardiology, rare disease, and medical devices. We operate under validated environments, maintain comprehensive audit trails, and produce deliverables that are submission-ready on first review — not after two rounds of regulatory queries.
- SDTM and ADaM dataset creation per CDISC standards
- Tables, listings, and figures (TLF) production for eCTD packages
- Define.xml, reviewer's guides, and PINNACLE 21 validation
- Integrated Summary of Safety (ISS) and Efficacy (ISE) programming
- Real-world evidence and post-market surveillance data analysis
What We Deliver
SDTM Implementation
Study Data Tabulation Model datasets built to CDISC IG specifications, with annotated CRF, SDTM mapping documents, and complete audit trail from raw to final.
ADaM Dataset Development
Analysis Data Model datasets (ADSL, ADAE, ADCM, ADLB, ADTTE, ADRS) aligned to your SAP, with full traceability back to SDTM source domains.
TLF Production
Statistical tables, listings, and figures produced to sponsor or CRO shells — with macro-driven quality checks to eliminate manual transcription errors from the process.
PINNACLE 21 Validation
Systematic validation of submission datasets against FDA and PMDA conformance rules — zero-issue packages that reduce back-and-forth with regulatory agencies.
Global Submissions Support
Submission packages prepared for FDA, EMA, PMDA, and Health Canada — formatting, data standards, and reviewer guide requirements aligned to each agency's current guidance.
Real-World Evidence Analysis
Claims data, EHR, and registry data programming using SAS for post-market surveillance, comparative effectiveness research, and HEOR deliverables.
Why Choose SWA for Clinical SAS
Certified Domain Expertise
Our clinical programmers hold SAS certifications and have direct experience at CROs and pharmaceutical companies — not contractors learning CDISC on your trial budget.
Validated Environments
All clinical SAS programming is performed in 21 CFR Part 11-compliant, validated environments with controlled access, version control, and complete change documentation.
Submission-Ready on Schedule
We've never missed a regulatory filing deadline on an engagement we owned. Our project management framework builds compliance checkpoints into every sprint, not just the final review.
Preparing a Regulatory Submission?
Tell us your timeline, therapy area, and submission target — we'll scope the programming work and confirm our availability within one business day.