We work directly with pharma, biotech, and CRO teams to implement reproducible, compliant R infrastructure — from initial setup through regulatory submission.
End-to-end support for implementing R in GxP environments. This includes validation strategy, standard operating procedures, system validation documentation, and ongoing compliance support tailored to your regulatory obligations.
Independent review of your R analysis pipeline. We identify reproducibility gaps, undocumented dependencies, and environment risks — and provide a prioritised remediation plan with practical recommendations your team can act on.
Validation of R and R packages to pharmaceutical industry standards. We produce Installation Qualification, Operational Qualification, and Performance Qualification documentation suitable for regulatory review and inspection.
ICH E9(R1) estimand strategy support for your clinical trial programme. From protocol estimand definition through SAP implementation, we help teams build estimand frameworks that are scientifically sound and regulatorily defensible.
Structured transition from SAS to R in regulated environments. We provide equivalence testing between SAS and R outputs, parallel validation documentation, and migration audit trails suitable for agency review — while maintaining your compliance posture throughout.
Tailored training for clinical statistics teams working in R. Topics range from R fundamentals and tidyverse through regulatory compliance, reproducible workflows, ICH E9(R1) estimand implementation, and Bayesian methods for regulated settings.
Every engagement starts with a conversation. We scope work carefully, deliver directly, and stay available throughout.
We discuss your environment, programme stage, regulatory context, and what you need to achieve. No obligation.
We define deliverables, timeline, and approach. Work is scoped to your specific situation — not a fixed package.
Work is delivered by Ndoh Penn directly. You have a single point of contact with direct expertise throughout.
We remain available after delivery for questions, regulatory queries, or follow-on work as your programme evolves.
Tell us about your environment and what you are trying to achieve. We will get back to you within 48 hours.
Or email team@reprosia.com