Multi-Site Trials.
Inconsistent Grading.
FDA Problems.
When Site A grades fatigue as Grade 2 and Site B grades identical symptoms as Grade 3, your trial integrity is compromised. Protocol deviations multiply. FDA questions pile up.
67% baseline agreement between oncologists at different sites
15% protocol deviation rate from inconsistent AE grading
6-month average delay in FDA review due to data quality issues
95.8% Inter-Site Agreement
AI-powered CTCAE grading ensures every site grades adverse events identically, every time. Automatic drug attribution, protocol deviation detection, and FDA-ready documentation.
95.8% consistency across sites
94% drug attribution accuracy
85% reduction in deviations
<2 hours for FDA reports
Why Trial Sites Struggle with CTCAE Grading
Inconsistent Grading Across Sites
Impact:
Different sites grade identical symptoms differently, creating data inconsistencies
Consequence:
FDA questions during submission, potential study integrity issues
Average 6-month delay in FDA review
67% baseline inter-rater agreement
Drug Attribution Disagreements
Impact:
Investigators disagree on which drug caused adverse event
Consequence:
Delayed safety reports, missed safety signals
$50K-200K per delayed SAE report
72% baseline attribution accuracy
Manual Safety Monitoring
Impact:
Retrospective analysis misses real-time safety signals
Consequence:
Patient safety risks, potential trial suspension
Immeasurable patient safety risk
15% protocol deviation rate
Built for Clinical Trial Excellence
Every feature designed to ensure trial integrity, regulatory compliance, and multi-site consistency.
95.8%
Inter-site grading agreement
94%
Drug attribution accuracy
85%
Reduction in AE-related protocol deviations
<2 hours
Time to generate FDA safety report
Trial-Specific Features
Standardized CTCAE Grading
AI ensures every site applies CTCAE criteria identically
Automatic Drug Attribution
AI analyzes timing, mechanism, and patient history for attribution
Real-Time Safety Monitoring
Detect concerning patterns across all sites instantly
FDA-Compliant Documentation
Auto-generate MedWatch forms and safety reports
Trial Cost Savings
$600K
Saved per multi-center trial
85% reduction in protocol deviations
6 months average
Faster FDA submission
= $30M in market value
50
Deviations prevented per trial
Across 20 sites
Ready to Ensure Trial Integrity?
Join clinical trial oncologists using Burna AI to achieve 95.8% inter-site consistency and faster FDA submissions.