抄録
When a pharmaceutical manufacturer develops a drug, various documents are produced in the process. For example: Statistical material of clinical trials, summary reports, and material for the medicine approval application submitted to the Ministry of Health and Welfare. In these documents, two major types of reports are used. One is case report tabulation where the clinical data are integrated, and another is statistical reporting where various statistics and results of tests are described. The system which is introduced here can produce statistical reports necessary during the process of medical drug development.