Built for Regulatory Submissions

PHARMA-STATS operates as a 100% R-based biostatistics CRO, delivering end-to-end statistical support across clinical and analytical research. Our work is grounded in scientific rigor, reproducibility, and regulatory-focused execution.

We work within a validated, GxP-aligned R environment, where analyses are developed through structured workflows with defined controls. Our approach follows principles from R Validation Hub, practices discussed at PHUSE and PharmaSUG, and aligns with ICH E9 and 21 CFR Part 11 expectations.

What This Means for Your Study

Every analysis we deliver is:

• Reproducible outputs with complete programs, logs, and traceable results
• Clear documentation from raw data to final outputs
• Regulatory-aligned analysis supporting submission review
• Efficient execution through structured workflows and automation.

Full transparency is maintained from data handling to analysis, with all transformations, models, and outputs explicitly coded, documented, and available for independent review and re-run.

Our R-Based Capability

We support the full lifecycle of statistical work:

• Study design & sample size (including adaptive designs)
• Randomization (including stratified and blinded structures)
• SAP development & mock shells
• TLF programming and statistical reporting
• CDISC (SDTM & ADaM) deliverables
• Bioequivalence, dissolution, and analytical evaluations

All deliverables are generated through a controlled R framework with:

• Package management using renv
• Version-controlled code (Git)
• Defined QC and validation processes
• Documented audit trails

All statistical programs are peer-reviewed and delivered with structured documentation, including program headers, change logs, and output metadata.