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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 statistical analysis (dose escalation, BA/BE, DDI, food effects, special population studies, etc.)

3. BE analysis (including drugs with high variation, narrow treatment window, long half-life, etc.)

4. PK  Clinical Trial Design and Consultation

5.Clinical trial design and consultation regarding with PK

6.Sample size/confidence calculation

7. PK Standardization (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.



Pharmacovigilance


•   Handling of individual safety reports (receiving, preliminary classification, input, quality control, medical review)  

•   Follow-up/challenge management of individual safety reports  

•  Scheme and CRF review (Security section)  

•  Safety Management Plan (SMP)  

•  DSUR/PSUR/ annual safety analysis report writing and review 

•  E2B electronic submission of case reports is supported  

•  Use and maintain PV database  

•  Safety data consistency verification support  

•  Writing of pharmacovigilance service commission agreement  

•  GVP system construction consulting support  

•  Other PV service support (such as literature retrieval, feedback data processing, etc.)