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ICH E6(R3) · 21 CFR Part 11 · EU CTR 536/2014

Clinical trial compliance, illuminated.

A living heat map that turns thousands of pages of regulation into a single, drillable view — every finding explainable, every signature audit-ready, every role its own experience.

6
Active studies
47
Mapped requirements
< 1 hr
To first insight
21 CFR 11
e-Signature ready
Live preview
Portfolio compliance · Study × Standard
Evaluated 3 min ago
ICH E6(R3)
21 CFR 312
EU CTR
Part 11
ARCADIA-3
92
on track
88
on track
76
watch
95
on track
HELIOS-2
84
watch
71
watch
88
on track
90
on track
ATLAS-1
68
critical
82
watch
91
on track
79
watch
SIRIUS-4
95
on track
90
on track
62
critical
87
on track
AI insight: Klinikum München projected to cross into red within 3 weeks — coordinator turnover pattern detected.
Choose your view

Built for every side of the trial

Hover or tap to flip. Each stakeholder sees only what they own — and how their piece connects to the whole.

Portfolio oversight
Sponsor
See every study, every signal, in one place.
  • Composite score across your portfolio
  • Predictive risk 3 weeks ahead
  • Delegated CRO oversight
Hover to flip →01 / 02
What you get as a Sponsor
  • Study × Standard heat map (ICH, 21 CFR, EU CTR)
  • Cross-site pattern detection
  • Inspection-readiness packages, one click
  • SUSAR & DSUR timeliness tracking
Site & study oversight
CRO
Multi-sponsor workspace with iron-clad segregation.
  • Study × Site oversight grid
  • Monitoring-visit compliance
  • AI-classified CAPA queue
Hover to flip →01 / 02
What you get as a CRO
  • Sponsor-scoped workspaces, zero data bleed
  • MVR timeliness & findings triage
  • AI-suggested CAPA drafts with citations
  • Signature workflows per sponsor SOP
Coordinator & PI
Site
Just what your site owes — no noise.
  • Requirement category tracker
  • Delegation & credential alerts
  • Re-consent progress at a glance
Hover to flip →01 / 02
What you get as a Site
  • Only your obligations — plain-language guidance
  • Guided remediation with evidence upload
  • PI e-sign, Part-11 compliant, on any device
  • Live projections when risk trends red
Explainable findings
Every score opens to the exact regulation clause, evidence, and confidence — AI or rule, always labeled.
Predictive trend lines
Site trajectories projected weeks ahead so you intervene before an inspection finding is inevitable.
Cross-site patterns
Detects the systemic gap hiding behind three unrelated deviations across studies and geographies.
21 CFR Part 11 sign-off
Ceremonial e-signature queue with reason-for-signing, tamper-evident audit, and role-scoped review.
Audit-first by design

Every click, every sign-off, every AI suggestion — traceable back to the source.

We never hide what the model decided or why. Reviewers see the model, the confidence, the reasoning, and the clause. That's how inspection-ready systems earn their name.

ICH E6(R3)
Fully mapped
21 CFR Part 11
e-Sign ready
EU CTR 536/2014
EU deployments
< 1 hour
To first value