Clinical Trial Documentation Dashboard
AI Assistant Insights
I've analyzed your trial documentation and found these insights:
Inclusion criteria discrepancy in sections 3.2 and 5.4 may require formal amendment.
All documentation for FDA quarterly submission is complete and verified.
Similar adverse event reporting patterns found across three study sites - may indicate training need.
Documentation Health
Updated 5 min ago by AIDocument Processing
Phase II Protocol Amendment 3
68% Complete
Recently Processed
Active Clinical Trials
FLUX-ONK-2025-003
Oncology - Phase II
FLUX-CARDIO-2024-001
Cardiovascular - Phase III
FLUX-NEURO-2024-007
Neurology - Phase I
AI Recommendations
Generate Trend Analysis
The system detected similar adverse event patterns across three trial sites that might provide valuable insights.
Review Protocol Inconsistency
AI detected potential inconsistency between inclusion criteria definitions in Section 3.2 and Section 5.4 of FLUX-ONK-2025-003 protocol.
Prepare FDA Submission
All documentation for quarterly FDA submission is complete. AI can assist in preparing the final package.
Recent Activity
Processed and analyzed Phase II Protocol Amendment 3 for FLUX-ONK-2025-003.
Uploaded 3 new safety reports for FLUX-CARDIO-2024-001 trial.
Generated comparative analysis of adverse events across all active trial sites.
Requested AI-generated protocol deviation analysis for FLUX-NEURO-2024-007.
Upcoming Deadlines
AI monitoredFDA Safety Report Submission
April 22, 2025
IRB Protocol Amendment Submission
April 25, 2025
Quarterly Data Monitoring Report
May 2, 2025