From Phase I to NDA. From clinical biostatistics to SAS migration. Reprosia scales with your regulatory obligation and clinical programme complexity.
Reproducible SAPs, locked environments at database freeze, automated audit trails for DSMB and regulatory review. Reprosia ensures your primary, secondary, and sensitivity analyses are reproducible from first draft to final submission.
Validate your R environment to FDA and EMA standards before submission. Generate complete IQ/OQ/PQ documentation automatically. Reduce the risk of submission audit failures from undocumented package dependencies or missing validation evidence.
Manage reproducibility and compliance across multiple sponsor environments and data governance frameworks. Deliver consistent, validated analyses regardless of client infrastructure, internal tooling, or regulatory jurisdiction.
Migrate from SAS to R without losing compliance posture or regulatory confidence. Reprosia provides automated equivalence testing, parallel validation, and complete migration audit trails acceptable for agency review — supporting teams at every phase of the transition.
Structured Bayesian prior elicitation, conflict diagnostics, and regulatory-ready prior justification reports. Aligned with the FDA 2026 draft guidance on Bayesian methods for drug and biological products.
Reproducible SAPs across all clinical trial phases. Locked environments at database freeze, automated DSMB audit trails, and NDA/BLA-ready submission packages.
Ensure biomarker analyses supporting companion diagnostic development and patient selection strategies are reproducible, auditable, and defensible in regulatory review.
Complete R environment validation before submission. IQ/OQ/PQ documentation, electronic records, and system validation evidence — automatically generated and ready for regulatory review.
Generate eCTD-ready statistical output packages from your R analyses. Module 5 outputs, define.xml, reviewer's guide — all with full traceability to source data and analysis code.
Manage distinct validated R environments per sponsor. Reprosia isolates sponsor environments while providing central oversight of validation status and compliance posture.
Guarantee identical outputs from multiple statistical sites. Reprosia synchronises environments across sites and flags any deviation before it reaches the submission package.
Migrate SAS macros and PROC code to R with automated equivalence testing. Reprosia compares outputs numerically and documents any differences with regulatory-acceptable justification.
Support your statistical programming team in transitioning to R without compromising compliance obligations. Reprosia provides guardrails, validation, and training integration throughout.
The FDA 2026 draft guidance on Bayesian statistical methods raises the bar for prior justification. Reprosia integrates bayprior to provide structured elicitation workflows, conflict diagnostics, and regulatory-ready prior justification reports directly in your submission package.
Leverage historical control data or prior trial evidence in your Bayesian design with principled, audit-ready methodology. Reprosia supports robust mixture priors, power priors, and sceptical priors — each with complete documentation for regulatory review.
Focus on the science. Reprosia handles environment documentation, audit trails, and reproducibility so your team writes statistics, not validation SOPs.
Locked environments, certified packages, and automated validation reports. Ship analysis code you can stand behind at a regulatory inspection.
Complete IQ/OQ/PQ documentation generated automatically. Submission-ready evidence packages that satisfy FDA and EMA reviewer expectations.
Real-time compliance monitoring, audit trail access, and validation status dashboards. Catch issues before they reach the inspection.
Platform-level visibility into your statistical computing compliance posture. Reduce submission risk and accelerate approval timelines.
Computerised system validation evidence generated automatically. Integrate Reprosia with existing GxP IT infrastructure and change control processes.
We work directly with pharma, biotech, and CRO teams to implement reproducible, compliant R infrastructure. Every engagement is hands-on, led by the founder.
End-to-end implementation of R in GxP environments. Validation strategy, SOPs, system validation, and ongoing compliance support.
Independent audit of your R analysis pipeline. We identify reproducibility risks and compliance gaps, with a prioritised remediation roadmap.
Validation of R and R packages to pharmaceutical industry standards. Full qualification documentation acceptable for FDA and EMA review.
ICH E9(R1) estimand strategy for your clinical trial programme — from protocol definition to SAP implementation.
Structured migration from SAS to R in regulated environments. Equivalence testing, validation bridging, and compliance throughout.
Prior elicitation, conflict diagnostics, and FDA 2026 Bayesian guidance implementation using the bayprior framework.
Every engagement starts with a conversation. We'll understand your environment and show you exactly how Reprosia fits.
Or email us at team@reprosia.com