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AI document classification
Auto-file via Trinity AI
21 CFR Part 11 audit trail
Electronic signatures
Inspection readiness score
Real-time gap analysis
Multi-user team management
Roles, permissions, notifications
Inspection package export
PDF, Excel, Word reports
TMF Auditor
Document review and approval
Messages
Group and personalised messaging
ICH E6(R3)21 CFR Part 11ISO 14155:2026
1
About you2
Your trial3
ScheduleTell us about yourself
SponsorCROTMF LeadCRA / CTAQARegulatoryOther
TMF360
Live
74%
Complete
12
Missing
89
Approved
78
Readiness
Readiness
Activity feed
Zone completeness
Trial Mgmt78%
Regulatory45%
Site Mgmt91%
Safety62%
IP & Supplies55%
Tell us about your trial
Phase IPhase IIPhase IIIPhase IVObservationalFeasibility
1-56-2021-5050+
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