Clinical Operations
- Regulatory document preparation
- Comprehensive Study Management
- IRB selection and sponsor submissions
- Site Selection and Qualification
- Site Regulatory tracking
- Selection and Management of Ancillary Vendors
- Investigator Meetings
- Routine Data Monitoring and Site Visits
- Development of Monitoring SOPs and Progress reporting per sponsor specifications.
- Medical monitoring (Urology)
- Data management
- Statistical analysis
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