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Statistics Service

Statistics Service



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

  • Create ADaM from SDTM for safety and efficacy analysis.

  • Perform ADaM PC21 validation.

3. TFLs

  • Create tables, figures, and listings of clinical study report for regulator and sponsor review.

4. Define

  • Create SDTM and/or ADaM define.xml for FDA/PMDA/EMA/SFDA.

  • E-submission review.