TrialSage Documentation

TrialSage is an AI-powered clinical trial management platform built for small-to-mid research sites and CROs managing 1–200 active studies.

What You Can Do

  • Manage Studies — Create studies with protocol numbers, phases, sponsors, and therapeutic areas. Track status through the full lifecycle: Setup → Active → Paused → Closed → Archived.

  • Manage Sites — Add research sites to studies with principal investigator details, location, and status tracking.

  • Enroll Subjects — Screen and enroll subjects at sites with consent date tracking, status transitions, and withdrawal management.

  • Track Everything — Every change is logged to an immutable audit trail with chained SHA-256 checksums, meeting 21 CFR Part 11 requirements.

  • Customize Your Experience — Choose your theme (light, dark, or system), font (DM Sans, Inter, or System), and density preference.

Getting Started

  1. Sign up at /signup with your email, name, and organization
  2. Create your first study from the Studies page
  3. Add sites to your study from the study detail page
  4. Enroll subjects at your sites

See the Getting Started guide for detailed instructions.

Architecture

TrialSage is built on three platforms:

  • Vercel — Next.js 16 frontend and API
  • Supabase — PostgreSQL database with Row-Level Security, Auth, and Realtime
  • Azure — Blob Storage for clinical documents (coming soon)

Every organization gets complete data isolation through PostgreSQL Row-Level Security policies. Your data is yours.