βœ“ HYGEIA β€” Compliance Checker

Achieve 97%
Compliance Accuracy

Named after the Greek goddess of health and hygiene, Hygeia automatically validates your protocols against FDA, EMA, and ICH-GCP guidelines with real-time feedback.

97%Accuracy Rate
200+Regulatory Rules
<30sAnalysis Time

Multi-Agency Validation

Comprehensive compliance checking across major regulatory bodies

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FDA

Food and Drug Administration

85+
Compliance Rules
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EMA

European Medicines Agency

72+
Compliance Rules
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ICH-GCP

International Council E6(R3)

50+
Compliance Rules

How Compliance Checking Works

Automated analysis in three simple steps

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Upload Protocol

Select any protocol from your dashboard

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AI Analysis

200+ rules checked in under 30 seconds

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Get Results

Issues categorized with auto-fix suggestions

See Compliance In Action

Real-time regulatory validation with detailed feedback

Protocol ABC-123 β€” Compliance Analysis
βœ“ Run Check
2
Critical Issues
5
Warnings
8
Informational
!
Missing informed consent language
Section 6.2 must include specific language about data privacy rights
FDA 21 CFR 50
⚠
Safety monitoring plan incomplete
Consider adding DSMB meeting frequency to Section 9.1
ICH E6 5.5
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Primary endpoints well-defined
Section 4.1 meets all ICH requirements for endpoint specification
ICH E9
94%
Overall Compliance
15 of 200 checks need attention
By Regulatory Body
FDA
94%
EMA
91%
ICH
97%

Better Together

Hygeia doesn't work aloneβ€”it's part of a unified ecosystem where every foundation enhances the others

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Hygeia
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Aglaea Integration

Compliance checks run automatically as you write. See issues highlighted in real-time within the protocol editor.

  • Inline compliance warnings
  • One-click auto-fix in editor
  • Section score indicators
Explore Aglaea
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Iaso Integration

After every amendment, Hygeia automatically re-runs compliance checks to catch any new issues introduced.

  • Auto re-check on changes
  • Compliance diff reports
  • Amendment impact scoring
Explore Iaso
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Aceso Integration

Each compliance citation links directly to the source regulation in Aceso's knowledge base.

  • Click-through to full guidance
  • Related regulation suggestions
  • Regulatory update alerts
Explore Aceso

Ready for Perfect Compliance?

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