CDISC SDTM & ADaM Dataset Programming
SDTM and ADaM preparation, transformation and review: mapping, derivations, metadata, QC and traceability between source data, SAP and outputs.
SAS & R Statistical Programming and TLF Delivery
We turn SAPs and shells into reproducible outputs for clinical review, study reporting and publication. Delivery includes programming and QC evidence, not only final files.
What you receive
- Tables, listings and figures identified by version and data cut.
- Programs, logs and associated specifications.
- QC evidence and a resolved/open discrepancy log.
Synthetic-data demonstration · Not client work
A figure showing the data and their uncertaintyDots: individual observations. Diamonds: means. Bars: 95% confidence intervals for each mean. Score in arbitrary units. 120 fictional participants, one measurement per participant; 60 per group.
| Group | n | Mean | SD | 95% CI for the mean |
|---|---|---|---|---|
| A | 60 | 49.80 | 9.38 | 47.38 – 52.23 |
| B | 60 | 46.32 | 12.57 | 43.07 – 49.56 |
Mean difference B − A: -3.48
Welch 95% CI: -7.50 – 0.53
Method and reproducibility
A simulated continuous variable in arbitrary units, with no clinical meaning. Independent groups generated from normal distributions with different variances; no covariates or missing data. Group confidence intervals use Student’s t distribution; the interval for the difference uses Welch’s method. This is neither a longitudinal nor an adjusted analysis. The interval for the difference includes zero: it does not establish equivalence or a clinical conclusion.
Generated with R and ggplot2; interaction with Plotly. Seed: 20260906. Not generated with SAS.
What is included
- Specify and programme safety, efficacy, longitudinal and exploratory TLFs.
- Use SAS Base, Macro and SQL, and R under sponsor conventions.
- Provide independent QC or peer review, discrepancy resolution and refreshes by data cut.
Frequently asked questions
Can we commission only QC of existing outputs?
Yes. We agree priority outputs, sources, specifications and review criteria to produce reproducible, verifiable findings.
Related services
SAS–R Modernisation & Programming Libraries
Modernise SAS macros and R workflows with reusable functions, TLF templates, QC automation, documentation and equivalence checks.
Discuss your project
Tell us about the objective, study stage and deadline. We review the need and availability; we then define the scope with you and prepare a proposal with deliverables, timing and fees.
Do not email patient, clinical or confidential study data. Access and the working environment are agreed before materials are shared.
Discuss your project