Datasets and outputs that hold up under review.

Programming is where protocol and statistical analysis plan become real numbers. Our statistical programmers work in SAS and R to build standardised datasets and outputs that are accurate, reproducible and traceable, from the first mapping specification through to the final submission package.

We work alongside your biostatisticians, data managers and regulatory colleagues, and we build to your sponsor standards or to current CDISC standards where you do not have your own.

What we do

  • SDTM dataset development. We map source data to SDTM domains, apply controlled terminology and keep the link back to source clear for reviewers.
  • ADaM dataset development. Analysis datasets built to the SAP: derivations, population flags, endpoint variables and metadata, with traceability from the analysis back to the source.
  • Tables, listings and figures. Efficacy, safety, demographic and baseline outputs programmed to approved specifications, with quality control built in.
  • Define-XML. Metadata that describes your datasets, variables, controlled terminology and derivations clearly enough for a reviewer to follow without calling you.
  • Pinnacle 21 validation and issue resolution. We run validation, investigate each finding, correct what needs correcting, revalidate, and document justification for exceptions that are legitimate.
  • Legacy data conversion. Moving older study data into CDISC structures: assessing what exists, writing mapping specifications and applying transformation with quality control.
  • Metadata review. Checking SDTM and ADaM metadata for completeness and consistency with the standards and study documents.
  • Independent quality control. Independent programming checks and risk-based review of structures, derivations, attributes and outputs.
  • ISS and ISE programming. Harmonised datasets and analyses across studies for integrated summaries of safety and efficacy.
  • Interim analysis and DMC or DSMB support. Programming and reporting for planned interim analyses and monitoring committees, handled under the confidentiality rules the study sets.
  • Programming automation. Reusable code, standard templates and automated checks that cut repetitive work and make results easier to reproduce.
  • Standards implementation and CDISC consulting. Help setting up or tidying sponsor standards, mapping conventions and reusable specifications, plus practical advice on interpreting the standards and resolving validation findings.
  • Submission support. Preparation, review and checking of datasets, Define-XML, validation reports, TLFs and supporting documentation.
SAS and R

We program in SAS and R. SAS is widely used in clinical statistical programming and regulatory submissions. We write SAS code to be readable, documented and reusable. We also support R-based workflows for reporting automation, visualisation and reproducible analysis, tailored to your team’s requirements. We can support the transition to R through controlled implementation, validation and quality review.

What we get
  • Standards-aligned deliverables built to approved specifications.
  • Independent review before anything reaches you.
  • Clear traceability from source to SDTM to ADaM to output.
  • Dedicated programmers, project teams or extra capacity for your own group.
  • Send us your specifications, a validation report or just a question about standards.