Medical Writing
- Study Design Consulting
- Protocol Development
- ICF Development
- Essential Document Development
- CSR(Clinical Study Report) Writing
- CTD Module 2(2.5,2.7) & Module 5
Clinical Operation (BE, Phase1~4)
- Recruiting investigational sites
- Supporting Regulatory Affairs group with regulatory authority submissions
- Clinical Trial Agreement
- Investigator’s meeting
- Pre-study Visit
- Monitoring Plan
- Project Management Plan
- Site Initiation Visit
- Monitoring Visit
- Non-routine Visit
- Close-out Visit
- IP Management
- Vendor Management
- Safety Management
- Audit/Inspection Readiness
Data Management / Statistical Analysis
- DMP Development
- EDC Development (CRScube)
- User Acceptance Test
- Query Management
- Data Manual Review
- Medical Coding(MedDRA)
- SAE reconciliation
- Data Cleaning
- Statistical Consultation
- SAP Development
- Statistical Analysis programming using SAS
- Sample size calculation
- Statistical Analysis Report Development