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DM/Statistical analysis

Data from a clinical trial under new GCP are correctly processed to build a database. The clinical data are statistically analyzed through our wealth of know-how, which MIC has been accumulating for years, and reasonable conclusion is drawn and compiled in a statistical report.

1. Support for preparation of protocol
(1)Planning, proposal, and support for preparing protocol
(2)Proposal of a statistical method and its review from scientific soundness

2. Support for preparation of CRF

3. Preparation of data management plan

4. Preparation of database specifications

5. Database design by applying audit trail system

6. Formulating input rules

7. Data input

8. Logical check

9. Coding

10. Management of data history

11. Preparation of statistical analysis plan and output plan

12. Performing statistical analysis in accordance with a statistical analysis plan
(1)Reviewing statistical method from scientific soundness
(2)Instruction of a statistical method to programmer
(3)Programming by SAS
(4)Creating charts and tables
(5)Preparation of documents for case study meeting including lists of cases
(6)Validation for the statistical analysis results

13. Support for Key Open through preparation of documents and analysis

14. Data analysis of pharmacokinetics/pharmacodynamics

15. Preparation of statistical analysis report

16. Support for preparation of a clinical study report

17. Support for preparation of investigator's brochure

18. Support for preparation of summary of approval application

19. Support for publication

20. Responses to inquiries from PMDA regarding approval application