Clinical Operations
- Clinical Monitoring
- Protocol Design
- Site Selection
- Clinical Study Management
- Site Identification and Feasibility
- Medical Writing
- Vendor Management
- Drug Safety Management
- Regulatory Services
- Assist and Guide in Designing and Conducting a Clinical trial
- Project Feasibility Evaluation
- Regulatory Authorities Liaison
- Document Preparation and submission, e.g., Investigational New Drug, New Drug Application
Abbreviated New Drug Application, Common Technical Document, Investigational Device Exemption/Premarket Approval.