Aurelyn AI · Trial|OS™
Clinical Evidence & Consistency Engine
◈ Study Compliance Dashboard CV-301 Phase III CVOT N=8,842 LIVE
USDM 4.0 — Study CV-301 · Cardivex (trevimab)
Phase III CVOT · Reduction of 3-pt MACE · 142 Sites · 32 Countries · N=8,842 · Protocol v3.1 · IND-128847
ICH E6(R3) 21 CFR 11/50/312 EU CTR 536/2014 HIPAA/GDPR ALCOA+ CDISC SDTM/ADaM eTMF RM v3.3 ICH E3
Overall Score
87
GOOD — Advisory Band
↑ +2.4% vs last period
Protocol
94%
Compliant
↑ +1.1%
Safety
91%
Compliant
↑ +0.8%
Data
89%
Advisory
↑ +3.2%
eTMF
81%
Advisory — Attention Required
↓ −0.5%
Regulatory
88%
Advisory
↑ +1.7%
Overall Compliance Score
Composite score across 5 domains · ICH E6(R3) · 21 CFR Part 11
0
GOOD
Trend ↑ +2.4%
Non-Compliant <75
Advisory 75–89
Compliant ≥90
5-Domain Compliance Breakdown
Score per domain · Overall avg 87% (dashed reference)
0255075100
Domain Radar
Pentagon balance view across all 5 compliance domains
Domain Score Cards
Individual domain status with compliance band
23 items · 3 critical · require immediate attention
eTMF Health Monitor
CDISC TMF RM v3.3 · 11 Zones
Data Collection Status
EDC / CTMS / Central Lab
API Connector Status
9 source system integrations