SDTM mapping
From raw EDC and source data to submission-ready SDTM, with traceable mappings, domain-level specifications and conformance validation.
Statistical programming
for clinical development
From SDTM and ADaM to TFLs, our statistical programming ensures compliant, submission-ready deliverables throughout the clinical development lifecycle.
Programming, end to end
ADaM datasets
Analysis-ready datasets with documented derivations, aligned with the SAP and traceable from SDTM to final outputs.
TFL programming
Tables, figures and listings aligned with the SAP for study reporting, CSRs and integrated analyses, with a clear and documented review trail.
Define-XML & reviewer guides
Define-XML, SDRG and ADRG developed alongside the datasets to support a coherent and review-ready submission package.
Double programming
Independent validation for pivotal analyses and other critical deliverables where reproducibility and confidence are essential.
Standards implementation
CDISC standards applied consistently, with sponsor-specific conventions implemented where required.
Legacy data conversion
Pre-CDISC, acquired and third-party data converted into consistent SDTM and ADaM structures for pooled analyses and submission programmes.
Tooling & automation
Reusable programming libraries, automated validation checks and standard output templates to improve efficiency while maintaining quality and control.
Submission readiness
Datasets, metadata, reviewer guides and programming deliverables prepared to support FDA, PMDA and EMA submission requirements.
Statistical programming you can defend
Our programmers build the datasets and outputs that carry the analysis into submission, keeping every step traceable from derivation through to the final eSubmission package.
Defensible by design
Every dataset, SDTM, ADaM, and every TFL behind a CSR is specified before it’s coded, validated as it’s coded, and traceable after lock.
SAS and R, used right
SAS for submission deliverables per FDA expectation; R for graphics, exploratory work, and derivations where the sponsor framework allows.
Inspection-ready
800+ studies supporting sponsor-led FDA, EMA, and PMDA submissions, with inspections closed with no critical or major findings.
Timelines that hold
Internal libraries, auto-validation, and a TFL template stack compress timelines without sacrificing rigour.
Core statistical programming capabilities
Standardized Data (SDTM)
CDISC SDTM mapping, validation, and submission-ready datasets.
Analysis Data (ADaM)
ADaM datasets with full traceability to SDTM and TFLs.
Data Integration Strategies
Pooled, integrated, and meta-analysis dataset architectures.
Our delivery approach
A four-phase delivery model in which specifications are agreed before programming begins, with quality control and validation integrated throughout the process.
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Spec
Mapping specifications, ADaM specifications and TFL shells aligned with biostatistics before programming starts.
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Build
SDTM, ADaM and TFLs developed with version control, peer review and documented implementation.
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Validate
Conformance checks, quality control and independent validation applied as required, including Pinnacle 21 and double programming for critical deliverables.
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Submit
Define-XML, reviewer guides and programming deliverables prepared in line with agency submission requirements and ready for upload.
Our programming expertise in numbers
800+ studies delivered
36 years of programming
CDISC aligned across SDTM + ADaM
95% staff retention
SAS and R, both supported
P21 validation built into every release
Operational questions sponsors ask
How do you ensure CDISC conformance?
Pinnacle21 validation built into every release, plus our own internal QC checks. Define-XML and ADRG are drafted alongside the datasets, not bolted on before submission.
Can you take over a programming engagement mid-study?
Yes. We have a structured handover protocol: review the existing code base and specs, validate against the lock, identify gaps, and re-baseline. Most takeovers preserve the sponsor timeline.
Do you operate sponsor-side standards libraries?
Yes — sponsor SDTM/ADaM library design and maintenance is a standard offering. Multiple sponsors use us as their long-term standards-governance partner across programmes.