AI-powered consistency validation and evidence traceability across your protocol, SAP, CSR, and regulatory submissions. Catch discrepancies before they reach regulators. Accelerate your submission quality review.
Platform Overview
Regulatory submissions are the culmination of years of clinical work — and a single discrepancy between documents can trigger a major amendment request, delay approval, or create compliance risk. The Clinical Evidence & Consistency Engine brings AI intelligence to the quality assurance challenge that's most critical and least automated: ensuring that your protocol, statistical analysis plan, clinical study report, and supplementary analyses tell a coherent, traceable, and consistent story.
The Clinical Evidence Engine receives study documentation from the eTMF Intelligence Engine and operational data from the Clinical Trial OS — ensuring that the evidence layer has complete, version-controlled access to all source documents from across the trial lifecycle.
Core Capabilities
From protocol review to final submission quality scoring — eight AI-powered capabilities that work together to ensure your clinical evidence is consistent, traceable, and regulator-ready.
How It Works
The Clinical Evidence Engine works continuously as your submission package develops — not as a one-time review gate at the end of the process.
Ingest your protocol and all amendments, the Statistical Analysis Plan, Clinical Study Report drafts, annotated CRF, all statistical outputs (TFLs), and relevant source documents. The engine creates a unified evidence index across the full document set.
AI traces every factual claim in the CSR to its source — data listings, literature references, regulatory precedents, or protocol-defined parameters. This creates a complete evidence map for your submission with gaps identified for human review.
The engine systematically compares all document pairs for consistency — Protocol vs. SAP, SAP vs. CSR, CSR vs. statistical outputs, and CSR vs. regulatory precedents. Every discrepancy is categorized by type, severity, and regulatory risk.
A comprehensive submission quality report prioritizes all identified issues by regulatory risk level. The report serves as the medical writer's and biostatistician's working document for the final quality cycle — with tracked resolution and sign-off capability.
Document Coverage
The engine covers all key documents in a clinical regulatory submission — and tracks consistency across every pair.
Built For
Ecosystem
The Clinical Evidence Engine integrates with your authoring, statistics, and regulatory publishing tools — and with the broader Aurelyn AI Clinical platform for full lifecycle intelligence.
See how the Clinical Evidence & Consistency Engine transforms submission quality from a last-minute scramble to a continuous, AI-supported process.