Clinical

• First-in human (FIH) clinical testing
• Translational science research and application
• Clinical testing strategy for Phase I, II, III and post approval studies
• Clinical trial operations (Project Management, Site Management, Monitoring etc.)
• Protocol design and development
• Author and evaluate clinical development plans
• Develop clinical trials strategy
• Generate and review Case Report Form design
• Adverse event reporting
• Statistical analysis plan generation
• Prepare invesitgators brochures
• Author and edit study reports, publications and regulatory submissions