Trusted by enterprises
Traditional review
Manual protocol reviews
Multiple document comparisons
Reviewer-dependent interpretation
Manual compliance assessment
Static review reports
Limited audit visibility
Governed by the elsai platform
Ai-assisted protocol intelligence
Automated evidence verification
Configurable validation rules
Continuous regulatory validation
Explainable AI recommendations
Complete audit trail and governance
Read success story →
01
Evidence-backed validation
Every finding is linked directly to supporting protocol text with confidence scores and explainable reasoning.
02
Human-in-the-loop
Clinical and regulatory experts review, approve, edit, or reject every AI recommendation before final sign-off.
03
Complete audit trail
Every validation rule, document version, reviewer decision, AI recommendation, and approval is fully recorded.
04
Configurable validation rules
Adapt protocol validation to evolving regulatory guidance and organizational standards without changing application code.
05
Operational monitoring
Monitor validation progress, compliance status, reviewer workloads, document quality, and protocol readiness through centralized dashboards.
06
Inspection ready
Generate evidence-backed reports with complete traceability for regulatory inspections and quality audits.
12–20 Wks → 4–7 wks
Faster initial CTIS submission preparation
15–25% → <3%
Reduction in CTIS technical rejection rate
$150K–$400k → $60k–$150k
Reduction in regulatory resource cost per submission
Ai-assisted human review focus
Reduction in manual regulatory effort per submission
What is a clinical trial protocol audit agent?
How does elsai validate clinical trial documents?
Can the clinical trial protocol audit agent identify compliance gaps before submission?
Does elsai replace clinical or regulatory reviewers?
How does elsai support audit-ready clinical workflows?
