Clinical data & statistical programming
SDTM/ADaM specifications and implementation, derivations, tables/listings/figures and documented QC. Reproducible workflows and Pinnacle 21 integration can support repeatable delivery where appropriate.
Life Sciences & Biostatistics
Clinical data, biostatistics and research support—from study question to reproducible results.
Bring a defined analysis work package or add specialist capacity to your study team. We combine bioinformatics and biostatistical expertise with R/Python/SAS engineering; a new pipeline or platform is not a prerequisite.
Discuss your study or analysisBiostatistics
Support for statistical planning, analysis-plan development, analysis, interpretation and reporting. We agree methods and review responsibilities against the study question and the team’s applicable experience.
Real-world data and evidence
Assess data fitness, missingness, cohort and endpoint definitions before analysis. Data preparation is not evidence generation: study design, bias, confounding and limits to interpretation need explicit consideration. Specialist method needs are assessed during scoping.
Research & bioinformatics
Research analysis, exploratory work and bioinformatics workflows informed by scientific understanding. We can scope evidence-synthesis needs alongside the research question; specialist methods and review requirements are agreed before committing to delivery.
Examples of scoped deliverables
- SDTM/ADaM specifications and analysis datasets
- Reproducible statistical code and tables/listings/figures
- Documented QC checks and review records
- Analysis and interpretation reports with stated limitations
Examples are scoped to the assignment, not a mandatory package. Sponsors retain study decisions and accountable review. Implementation and QC support do not constitute regulatory approval, guaranteed submission acceptance or certified validation.
Illustrative workflow—not a customer case study.
- 01Source data
- 02Harmonization & metadata
- 03SDTM / ADaM
- 04QC & review
- 05TLFs & applications
Before we start
Can we commission just one analysis?
Yes. A defined work package or specialist contribution can cover an analysis, derivation, report or QC task without a platform project.
What should we bring?
The study question, available data structure, approved specifications and review arrangements. Agree a secure transfer route before sharing data; do not upload health data through the inquiry form.
Case Studies
Selected engineering projects
Anonymized project experience in Financial Services, Life Sciences and self-hosted AI automation, with concrete approaches, results and lessons learned.
Life Sciences & Biotechnology
Client software delivery · AI-assisted development
AI-Assisted Audit Trail Reporting for an International Life Sciences Company
Human-reviewed AI-assisted development of structured audit trail reporting, with attention to maintainability, traceability and reproducibility.
Read the case studyThe audit-trail project demonstrates life-sciences software delivery and human-reviewed AI-assisted development. It is not a clinical trial analysis or an RWD/RWE outcome claim.
Contact
Discuss your study or analysis
Tell us what you need to analyse, build or maintain. We will clarify the scope and suggest an appropriate next step.