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.
80%
Faster AE Reporting
From event occurrence to EDC submission
95%
Compliance Rate
FDA 21 CFR Part 11 and ICH-GCP standards
73%
Query Reduction
Fewer data clarification requests from monitors
45%
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.
FDA 21 CFR Part 11 Compliance
Electronic signatures, audit trails, and data integrity validation
- Electronic signature validation
- Comprehensive audit trails
- Data integrity controls
- User access management
ICH-GCP Standards
International guidelines for clinical trial conduct and reporting
- Protocol deviation tracking
- Source data verification
- Quality assurance metrics
- Regulatory reporting templates
eCTD Ready Reporting
Automated generation of regulatory submission documents
- Structured safety data
- Pre-formatted reports
- Submission timelines
- Version control
Real-Time Monitoring
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.
Medidata Rave
Native API
Integration Features:
- Real-time CTCAE data sync
- Automated form population
- Query prevention
- Instant validation
Performance Impact:
Data Entry Speed
5x Faster
Data Quality
99.1%
Query Rate
-73%
Intelligent Workflow Automation
AI-powered automation handles routine tasks, freeing you to focus on patient safety and trial quality.
Adverse Event Detection
Intelligent AE identification from clinical notes and patient reports
AI scans patient records
Identifies potential AEs
Suggests CTCAE grades
Triggers reporting workflow
Regulatory Reporting
Automated generation of SAE reports and regulatory submissions
Collects AE data
Applies regulatory timelines
Generates compliant reports
Submits to authorities
Protocol Deviation Tracking
Real-time monitoring and documentation of protocol deviations
Monitors protocol compliance
Flags potential deviations
Documents root causes
Tracks corrective actions
Data Quality Assurance
Continuous validation and quality control of trial data
Validates data entries
Identifies inconsistencies
Generates quality reports
Tracks resolution status
Quantifiable Trial Acceleration
See the concrete financial and operational benefits of implementing CTCAE AI in your clinical trials.
Annual ROI for Clinical Trial Coordination
$439,000
Based on Phase II/III oncology trial (150-300 patients)
Time Savings
CTC time reduction: 15 hours/week × $35/hour × 52 weeks
$127,000
Query Reduction
73% fewer queries × 8 hours resolution × $45/hour × 280 queries
$89,000
Faster Recruitment
45% faster enrollment × improved trial timelines
$156,000
Compliance Efficiency
Reduced audit preparation and regulatory submission time
$67,000
Implementation Cost
Software + Training + EDC Integration
$78,000
Net ROI:
$361,000
ROI of 463% in first year
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."
Senior Clinical Trial Coordinator
National Cancer Institute
Key Result:
45% faster patient enrollment
"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."
Clinical Research Coordinator
Johns Hopkins Oncology
Key Result:
80% reduction in data entry time
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+Ready to Accelerate Your Clinical Trials?
Join leading research centers using CTCAE AI to improve trial efficiency, ensure regulatory compliance, and deliver life-saving treatments faster.
✓ FDA 21 CFR Part 11 compliant ✓ 30-day trial period ✓ Dedicated regulatory support team