Custom Study Design, Therapeutic Expertise
1. Protocol Development
- Study Design, Method, Period, Therapeutic Area
2. Study Design & Feasibility Assessment
- Study Feasibility, Site Selection, Subject Recruitment
3. Regulatory Strategy & Submission Support
- Approval from MFDS, IRB, Ethics and IRB Submission Support etc
4. Site and Investigator Selection
5. Clinical Monitoring Plan Development
6. Data Collection and Management Support
- Setting up EDC systems, data entry, and verification.
7. Statistical Analysis Planning
8. Safety Monitoring & Reporting