Statistical Analysis Plans
SAP development for IDE, PMA, and 510(k)-support studies, written to FDA and ICH E9 standards.
§ 1 Services
Statistical work for the full regulatory path
Small and mid-size sponsors need rigorous statistics to reach the market, but a full-time biostatistician often doesn't fit the org chart yet. I step in wherever the statistical workload sits.
Behind this pagePower curves for a two-arm trial, two-sided α = 0.05, standardized effect δ = 0.25 to 0.7. Dots mark the n per arm for 80% power.
Clinical Study Reports
Full CSR authoring and statistical review, including executive summary, methods, and results sections.
Tables, Figures & Listings
Production-ready TFLs built in R or SAS, formatted for regulatory submission packages.
Interim & Final Analyses
Pre-planned and ad hoc analyses with proper multiplicity controls and data monitoring support.
Post-Market Surveillance
Statistical support for PMCF studies, MDR trend analyses, and complaint data review.
SAS & R Programming and Validation
Custom SAS programs and R scripts, reproducible workflows, and documentation suitable for Part 11 environments.
Trial Design & Sample Size
Feasibility and pivotal design, sample size calculation, and randomization schemas for device and drug studies.
EDC Build & Data Management
Clinical database builds in modern EDCs, plus data integrity, query resolution, and database lock.