Developed AE monitoring structure improving safety documentation accuracy by 10% and streamlining coding workflows.
• MedDRA Coding
• AE Monitoring
• SOP Compliance
• Data Accuracy
• Safety Reporting
Proposed workflow improvements increasing daily sample throughput by 25% and reducing processing delays.
• Process Mapping
• Data Review
• Workflow Optimization
• Clinical Documentation
• QC Checks
Collected inpatient data, designed CRF-style tools, and analyzed 600+ entries identifying key medication return trends.
• CRF Design
• Data Validation
• Statistical Review
• Documentation
• Trend Analysis