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. Never fail a submission audit because of an undocumented package dependency 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.
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.
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.
Every engagement starts with a conversation. We'll understand your environment and show you exactly how Reprosia fits.
Or email us at ndoh@reprosia.com