Service
Statistical Programming
CDISC-conformant SDTM and ADaM datasets and TLFs with documented, validated programs.
Overview
Submission-quality programming is as much about traceability as it is about code. Every dataset and output should trace back to its source and its specification.
We build to the CDISC standards, validate independently where required, and deliver the metadata and documentation reviewers expect to see.
Standards & frameworks we work within
- CDISC SDTM, SDTMIG, ADaM, ADaMIG
- CDISC Define-XML
- CDISC Controlled Terminology
- Regulatory data standards guidance (e.g. FDA Study Data Technical Conformance Guide)
These are frameworks we work within or align to. They do not imply certification, accreditation or endorsement.
What we deliver
- SDTM mapping specifications and dataset programming
- ADaM specifications and analysis dataset programming
- Tables, listings and figures (TLFs)
- Define-XML and reviewer's guide support
- Independent double programming and QC
- Program documentation and reproducible environments
Typical deliverables
- SDTM and ADaM datasets
- Define-XML and supporting metadata
- TLF packages
- Validation and QC documentation
Engagement models
Project-based
A defined scope, timeline and set of deliverables agreed up front.
Dedicated capacity
Specialists embedded in your workflow on a longer-term, scalable basis.
Advisory & ad hoc
Targeted expert input, reviews or surge support when you need it.
Frequently asked questions
Service descriptions are general and informational. Scope, responsibilities and outputs are defined in a written agreement for each engagement.
Explore other services in the services overview.
Discuss statistical programming
Tell us about your programme. We’ll respond with an honest view of how we can help, and where we can’t.