Upload study documents. Get ICH M11 compliant clinical protocols in minutes — not months. Built for medical writers and clinical teams.
Regulatory Frameworks
Contents
PROTOCOL SUMMARY
INTRODUCTION
OBJECTIVES & ENDPOINTS
STUDY POPULATION
STUDY INTERVENTION
Protocol #: AUR-2026-0042 Version: 1.0 Sponsor: Acme Therapeutics
Capabilities
Generate clinical study protocols, investigator brochures, and clinical study reports with advanced AI technology.
Built-in compliance for all jurisdictions including FDA, EMA, TGA, MHRA, KFDA, NMPA, and PMDA amongst other regulatory authorities.
Comprehensive support from Phase I through Phase IV, adapting documentation requirements for each study phase.
How It Works
Upload study objectives, endpoints, population criteria, and regulatory requirements to our secure platform.
Advanced AI generates protocols, investigator brochures, and study reports tailored to your specific trial phase and jurisdiction.
Receive compliant clinical documents formatted for submission to regulatory authorities worldwide.
Frequently Asked Questions
Auralis generates protocols following the ICH M11 (CeSHarP) 14-section template structure, which is accepted by FDA, EMA, TGA, MHRA, PMDA, NMPA, and KFDA. The output is designed to meet global regulatory expectations across all major jurisdictions.
Yes. Every section of the generated protocol is fully editable in our built-in viewer. You can modify text, update structured fields, and export the final version as DOCX or PDF. Medical writers retain full control over the output.
All uploaded documents are encrypted in transit and at rest. We use Supabase for secure storage with row-level security policies. Your study data is never used to train models and is only accessible within your account.
Auralis accepts PDF, DOCX, DOC, and TXT files. You can upload multiple documents per protocol — study synopses, investigator brochures, statistical analysis plans, or any supporting study documents.
Auralis uses a multi-agent architecture with state-of-the-art language models from Anthropic and OpenAI. Specialized agents handle different protocol sections, with built-in search tools for PubMed, clinical trial registries, and regulatory guidance.
A full 14-section ICH M11 protocol is typically generated in 3–8 minutes, depending on the complexity of the study and the volume of uploaded source documents.
Join pharmaceutical companies streamlining their clinical documentation with AI-powered automation across all trial phases.