Ensure Bulletproof Compliance with AI
Maintain 100% regulatory compliance with AI-powered CTCAE grading that automates FDA 21 CFR Part 11 requirements, streamlines NCI audits, and ensures enterprise-grade security across all operations.
FDA 21 CFR Part 11 Compliance
Electronic signatures and audit trails
Audit Success Rate
First-pass regulatory audit approval
Faster Audit Prep
Automated documentation generation
Compliance Automation
Automated regulatory workflows
Comprehensive Regulatory Compliance
Built-in compliance with all major regulatory frameworks and international standards for clinical research and healthcare data management.
Complete electronic records and signatures compliance
- Electronic signature validation
- Audit trail integrity
- User access controls
- Data backup and recovery
- System security controls
International guidelines for clinical practice compliance
- Protocol adherence tracking
- Investigator qualifications
- Quality assurance procedures
- Data integrity monitoring
- Adverse event reporting
Protected health information security and privacy
- Data encryption at rest
- Transmission encryption
- Access logging and monitoring
- User authentication
- Breach notification
Security, availability, and confidentiality controls
- Security control testing
- System availability monitoring
- Processing integrity validation
- Confidentiality controls
- Privacy protection measures
Automated Audit Preparation
Stay audit-ready 24/7 with automated documentation generation and real-time compliance monitoring.
Food and Drug Administration
Frequency: On-demand
Automated Deliverables:
- Complete documentation package
- Electronic records validation
- Audit trail generation
- Investigator file preparation
Compliance Status:
Intelligent Compliance Automation
AI-powered automation handles routine compliance tasks, monitors regulatory requirements, and ensures continuous adherence to all applicable standards.
Automated generation and submission of regulatory reports
Real-time audit trail generation and validation
Continuous compliance risk monitoring and mitigation
Automated training compliance and certification tracking
Real-Time Compliance Monitoring
Continuous monitoring and assessment of compliance risks with predictive analytics and automated remediation.
Overall Compliance Score
Data Integrity
Audit Readiness
Training Compliance
Documentation
System Security
Protocol Adherence
Compliance Insights:
- • All critical compliance areas operating above 90% threshold
- • System automatically resolved 12 potential compliance issues this week
- • Next scheduled audit in 45 days - all systems ready
Quantifiable Compliance ROI
See the concrete financial benefits of implementing AI-powered compliance management.
Based on multi-site clinical research organization
Trusted by Compliance Leaders
See how compliance officers are achieving perfect audit results and regulatory excellence with CTCAE AI.
"CTCAE AI has made our compliance program bulletproof. We passed our last FDA inspection with zero observations. The automated audit preparation is a game-changer."
"The regulatory automation has saved us thousands of hours annually. We're now able to manage compliance across 15 sites with the same team size. The ROI is incredible."
Enterprise Security & Validation
Bank-level security with comprehensive validation documentation for regulatory submissions.
Multi-layered security architecture with continuous monitoring
- SOC 2 Type II certified
- ISO 27001 compliant
- HIPAA secure
- Penetration tested
Complete validation documentation for regulatory submissions
- IQ/OQ/PQ protocols
- Risk assessments
- Validation reports
- Change control
24/7 compliance monitoring with automated alerting
- Real-time monitoring
- Automated reporting
- Trend analysis
- Predictive alerts