
Data Management:
1. Case Report Form (CRF) Design
2. (e)CRF Design Specification
3. Database Design
4. Edit Check Programming
5. Provide Custom Function
6. Draft Data Management Plan (DMP)
7. Data Entry and Lab Data Management
8. Medical Coding which use MedDRA and WHO Drug dictionary
9. Quality Control
10. External Data Management
11. SAE Reconciliation
12. Protocol Deviation Handing and Reconciliation
13. Provide Data Management Report
14. Provide DM Status Progress Report
PK/PD/BE Statistical Analysis
1. NCA & Compartment Model Analysis
2. PK/PD(NLME)
3. Bioequivalence Data Analysis Service
4. PK Related Clinical Trial Design and Consultation
5. PK CDISC
Statistical Analysis and Programing:
1. SDTM
Create SDTM from EDC, Lab, Coding, etc.
Tracking Data Issue.
Perform SDTM PC21 validation.
2. ADaM
3. TFLs
4. Define