Accelerate Clinical Trials with AI
Streamline trial coordination with AI-powered CTCAE grading that reduces AE reporting time by 80%, ensures FDA compliance, and accelerates trial timelines through intelligent automation.
Faster AE Reporting
From event occurrence to EDC submission
Compliance Rate
FDA 21 CFR Part 11 and ICH-GCP standards
Query Reduction
Fewer data clarification requests from monitors
Trial Acceleration
Faster patient recruitment and data collection
Built for Regulatory Excellence
Comprehensive compliance features designed to meet FDA, ICH-GCP, and international regulatory standards for clinical trial conduct.
Electronic signatures, audit trails, and data integrity validation
- Electronic signature validation
- Comprehensive audit trails
- Data integrity controls
- User access management
International guidelines for clinical trial conduct and reporting
- Protocol deviation tracking
- Source data verification
- Quality assurance metrics
- Regulatory reporting templates
Automated generation of regulatory submission documents
- Structured safety data
- Pre-formatted reports
- Submission timelines
- Version control
Continuous oversight of trial data quality and compliance
- Risk-based monitoring
- Deviation alerts
- Quality metrics dashboard
- Trend analysis
Seamless EDC Integration
Connect with your existing Electronic Data Capture system for immediate productivity gains and enhanced data quality.
Native API
Integration Features:
- Real-time CTCAE data sync
- Automated form population
- Query prevention
- Instant validation
Performance Impact:
Intelligent Workflow Automation
AI-powered automation handles routine tasks, freeing you to focus on patient safety and trial quality.
Intelligent AE identification from clinical notes and patient reports
Automated generation of SAE reports and regulatory submissions
Real-time monitoring and documentation of protocol deviations
Continuous validation and quality control of trial data
Quantifiable Trial Acceleration
See the concrete financial and operational benefits of implementing CTCAE AI in your clinical trials.
Based on Phase II/III oncology trial (150-300 patients)
Trusted by Leading Research Centers
See how clinical trial coordinators are accelerating trials and improving data quality with CTCAE AI.
"CTCAE AI has revolutionized our trial coordination. We're enrolling patients 45% faster and our data quality scores have never been higher. FDA audits are now stress-free."
"The EDC integration is seamless. What used to take hours of data entry now happens automatically. Our sponsors are impressed with the data quality and timeline improvements."
Rapid Trial Integration
Get up and running quickly with minimal disruption to ongoing trials.
Trial Assessment
Protocol review and EDC system integration planning
Week 1System Configuration
EDC connection setup and CTCAE customization
Week 2Team Training
Comprehensive training for coordinators and investigators
Week 3Live Deployment
Full production with 24/7 support and monitoring
Week 4+