Statistical Analysis Plan Generator

Generates a complete, regulatory-grade SAP modelled on real industry documents (ICH E9/E9(R1) compliant) — cover page, amendment history, objectives, analysis sets, endpoint derivations, full statistical methods, appendices

Study Parameters
Two AI passes · usually 40–70 seconds
Document sections generated:
  • Cover page & signature blocks
  • Complete Table of Contents (3-level)
  • 40+ Abbreviations
  • Amendment History table
  • Study Objectives (tabular, primary/secondary/safety/exploratory)
  • Study Design with Visit Schedule table
  • Sample Size & Power calculations
  • Analysis Sets (FAS, PPS, SAF, PK, ADA)
  • Protocol Deviations
  • Endpoint Derivations with Censoring Rules
  • PRO Variables & scoring
  • Full Statistical Methods (multiplicity, models)
  • Safety Analysis Methods (AESI, Hy's Law)
  • Missing Data strategy (ICH E9(R1))
  • Interim Analysis plan (O'Brien-Fleming)
  • Sensitivity & Subgroup Analyses
  • References & Appendices
Statistical Analysis Plan — awaiting generation
Generated Error

Your SAP will appear here

Fill in the parameters on the left and click Generate Full SAP

The generator makes two AI passes to produce a document comparable in depth to real industry SAPs (AstraZeneca TOPAZ-1, etc.)

Generating Statistical Analysis Plan…
Pass 1 of 2 — Cover page, TOC, Abbreviations, Amendment History
Pass 1 of 2 — Study Objectives, Design, Sample Size
Pass 1 of 2 — Analysis Sets, Endpoint Derivations, PROs
Pass 2 of 2 — Statistical Methods, Multiplicity, Models
Pass 2 of 2 — Safety Analysis, Missing Data, Interim Analyses
Pass 2 of 2 — Sensitivity Analyses, References, Appendices
Assembling final document…
Two AI passes — typically 40–70 seconds