Scope of Service
A. Clinical Project Management
- Early Phase I/IIa
- Phase IIb/III
- BioTech/Pharma/Research Institute
- Drug & Device
- Chinese Medicines
- Functional Food & Cosmetics
- Investigator Initiated Trial Management
- Venders Management
- Supply Chain Management
- Essential Document Management
- Meetings & Training
B. Clinical Operations
- Feasibility Assessments
- Investigator and Site Selection
- Monitoring
- Site Management
C. Data Management & EDC Management
- Electronic Data Capture (EDC)
- Data Management Plan
- Database Design and Validation
- Data Validation
- Medical Coding
- SAE Reconciliation
- Data Transfer
D. Statistical Analysis
- Statistical Consulting
- Statistical Analysis Plan (SAP)
- Randomization
- Statistical analysis programming for
Results and Output
E. Medical Writing & Regulatory Service
- Protocol Development
- Informed Consent Forms Development
- Case Report Forms Development
- Clinical Study Report Writing
- Regulatory (HA, IRB) Submission
- Consulting