Business Performances 

As of 28th Dec 2023 

1.Auditing Services (Japan and overseas)

• GCP Investigator Site Audit: 121 (Industry sponsored Clinical Trials: 80, Investigator-initiated clinical trials: 11)
•  GCP system Audit: 24 (Industry sponsored Clinical Trials: 19, Investigator-initiated clinical trials: 5)
•  GPSP/GVP Audit: 10
•  Clinical Research: 18 (Clinical Trial Act: 15, Others: 3)

２．Consulting on planning and implementation of clinical trials and Clinical Researches

•  Industry (Bio-Pharma and CRO : 15 companies
•  Clinical investigator Site: 4 site

 ３．Regulatory Inspection Readiness (Pre-Inspection Audit, Document Review and Mock Inspection)

•  PMDA inspection: 20 cases / 2 companies
•  Overseas Regulatory inspection: 2 cases / 2 companies 
•  Pre-Inspection Audit: 13 cases / 2 companies
•  Mock inspection: 2 cases / 2 companies 

 ４．Educational Training for Clinical Research Professionals

•  Industry: 10 companies
•  Clinical Investigator Site: 6 site
•  Association / Industry Group: 5 organization