Clinical Study Report Narrator

What it does

Converts raw clinical trial statistical outputs into ICH E3-compliant
CSR narrative drafts — covering primary and secondary endpoints.

Input formats accepted

CSV, Excel, SAS/R/Python outputs, PDF tables

What you get

• Narrative in English or Spanish
• DRAFT markers at top and bottom
• Inline ⚠️ flags for missing CIs, unspecified populations, ambiguous data
• Structured Review Flags section at the end

Who it's for

Medical writers, CROs, regulatory affairs teams in pharma.

Example input

Primary Endpoint: HbA1c change at Week 24
Treatment: -1.3% (n=52), Placebo: -0.4% (n=51)
p=0.048, 95% CI: not available

Example output

Narrative with ICH E3 language + inline flag for missing CI