AI-Driven Reportability You Can Trust

Intelligent triage for adverse events and medical device reporting.

Automated compliance meets regulatory excellence.

75K+

Cases Triaged

210K+

Reports Generated

45K+

Hours Saved

99%

Accuracy in Routing

Watch CollabTriage AI In Action

See how our AI engine powers efficient adverse event processing with high precision.

00:00:00

Automated Triage

Automatically determine reportability with high precision.

Rapid Processing

Reduce processing time from days to minutes.

Regulatory Compliance

Ensure adherence to global reporting standards.

Intelligent AI, At your fingertips

Intelligent Adverse Event Triage

Powerful AI-driven capabilities that transform pharmacovigilance case processing and regulatory reporting.

Medical Device Reportability

AI-driven decision support for reportability evaluation on adverse events.

  • FDA MDR compliance
  • Automatic case classification
  • Regulatory deadline tracking

Product Quality Triage

Advanced pattern recognition identifies quality trends and potential product issues.

  • Trend analysis
  • Signal detection
  • Risk profiling

Case Medical Compliance

Automated validation ensures every case meets regulatory medical review standards.

  • MedDRA coding validation
  • Causality assessment
  • Seriousness criteria check

Built-in Regulatory Compliance

Enterprise-grade compliance with global pharmacovigilance and medical device reporting standards.

FDA 21 CFR Part 11

Full compliance with FDA electronic records and signatures requirements for pharmacovigilance.

  • Electronic signatures
  • Audit trail integrity
  • Access controls

EU MDR

European Individual Case Safety Report standards with automated EudraVigilance submission.

  • ICH E2B compliance
  • EudraVigilance integration
  • XML validation

Data Security

Enterprise-grade security with encryption and role-based access for sensitive safety data.

  • End-to-end encryption
  • SOC 2 Type II certified
  • HIPAA compliant

Implementation Process

A seamless integration process engineered to maximize minimal operational downtime.

1

Assessment

Comprehensive analysis of your case volumes, workflows, and regulatory requirements.

  • Case volume analysis
  • Workflow mapping
  • Requirements gathering

2

Configuration

Custom AI model training and business rules tailored to your products and regulations.

  • AI model training
  • Audit Business rules setup
  • Product catalog integration

3

Integration

Seamless connection with your safety database and comprehensive team training.

  • Safety database integration
  • User training & certification
  • Validation & testing

4

Optimization

Ongoing monitoring and continuous improvement of triage accuracy and efficiency.

  • Performance monitoring
  • Model refinement
  • Continuous support

Pharmacovigilance Challenges We Solve

CollabTriage AI addresses the most critical pain points in adverse event processing and regulatory reporting.

Manual Processing Delays

Manual case triage and reportability assessment creates bottlenecks and compliance risk.

  • Automated case intake
  • Instant reportability determination
  • Real-time processing

Inconsistent Classification

Varying interpretations lead to classification errors and regulatory inconsistencies.

  • Standardized AI logic
  • Consistent decision-making
  • Audit trail documentation

Regulatory Risk

Missed deadlines and reporting errors expose organizations to regulatory penalties.

  • Automated deadline tracking
  • Compliance validation
  • Regulatory alerts

Ready to transform your pharmacovigilance workflows?

Join organizations using CollabTriage AI to automate adverse event processing and ensure regulatory compliance.