Trusted by enterprises worldwide
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Submission Prep
Manual submission prep takes 10–14 weeks per country package. 40% of that is avoidable rework.
02
Regulatory Rework
47% of submissions trigger an RFI from national competent authorities - forcing weeks of rework before trial initiation even begins.
03
Cross-Document Validation
Small inconsistencies across protocols, consent forms, and recruitment materials often lead to avoidable IRB rejections and review delays.
A governed intelligence layer that runs inside your regulatory operations - not on top of them.
elsai doesn't replace your CTMS, eIRB, or document authoring tools. It wires a governed execution layer directly into them — automating cross-document validation, per-country compliance checks, and submission assembly while your regulatory leads retain full sign-off authority.
EU CTR Domain Intelligence
Per-country rulesets for EU CTR Part I, CTIS fields, and Part II requirements — built in, not bolted on.
Human Authority Protected
Every submission bundle reviewed and approved by a qualified regulatory lead before it exits. EU AI Act high-risk classification compliant. Always.
Full Traceability
Agent Resource Management System logs every extraction, validation, and submission decision. Defensible audit trails without additional documentation overhead.
Works on your infrastructure
Veeva Vault
Medidata Rave
CTIS
EMA Gateway
Runs on AWS
Azure
On-Premise
See your document mismatches before the IRB does
THE PROBLEM IT SOLVES
One minor inconsistency.
Weeks of rework.
Writers, physicians, and regulatory and QA teams manage multiple Word and PDF files simultaneously under tight deadlines. Age ranges, schedules, risks, compensation - any mismatch triggers IRB rejections and costly modifications required cycles.
IRB Rejection
Modifications Required Cycles
Weeks of Rework Per Study
WHAT IT DOES
Collect & version
all study documents
Extract key info
across all of them
Verify consistency
flag every mismatch
Side-by-side
review summary
Audit-ready report
for IRB / sponsor
WHO USES IT
Medical Writers and Clinical Scientists
Regulatory Affairs and IRB Liaisons
Principal Investigators
Site Staff
Integrate with what you have. Run on what you trust.
Whether you're managing defense suppliers, aerospace programmes, regulated healthcare vendors, or financial services partners, elsai provides a governed operational layer across any procurement workflows.
Begin with one study. Standardise across your portfolio.
01
02
STEP 2
Connect your CTMS, eIRB, and document repositories. The agent works alongside Word, Google Docs, and sponsor templates — your team drafts the same way they always have.
03
STEP 3
Run on one study, review findings with your regulatory and QA teams, then expand across more studies, amendments, and sites.
EU regulatory submission is complex. Production-grade automation is hard. We close that gap - one workflow at a time.
Ready to see governed AI workflows inside your regulatory operations?
Bring a real study to the demo. We'll show you the mismatches before your IRB does.
Book a life sciences demo →
Talk to us →
