Profile

 1990-2011 
Bayer Yakushin Ltd, / Clinical Development  | Monitoring- Study management
2011 – 2020 
AstraZeneca K.K. / Quality Assurance (QA, Asia Pacific*)
 - GCP Auditing- Regulatory Inspection Management *Japan, China, Taiwan, South Korea, Thailand, Vietnam, Indonesia, India
2020 – 2021 
Graduate School of Pharmaceutical Sciences, The University of Tokyo /IT Healthcare Social Collaboration Course, Project Researcher,  Remote Auditing Model- Utilization of ICT in IRB as a Countermeasure Against COVID-19 outbreak- Patient and Public Involvement in Drug Development- Public Engagement in Medical Care
2020 – present 
Tutti Quality Assurance Network / President
Auditing services (GxP, Clinical Research)-   Consulting on planning and implementation of clinical trials and Clinical Researches   (Industry, Academia and Clinical Investigator Sites)-   Regulatory Inspection Readiness (Pre-Inspection Audit, Document Review and Moc     Inspection etc. )-   Educational Training for Clinical Research Professionals (including supporting for the exam taker of global certifications)
2021 – 2023 
National Center for Neurology and Psychiatry/ Research Fellow
- Clinical Research Auditing
2023 – present 
Osaka University Hospital, Department of Medical Innovation, Associate Professor (Specially Appointed)
  - Quality Assessment for Certified Review Board (CRB)
 Hiroshima University Hospital, Clinical Research Center in Hiroshima, Professor (Specially Appointed) 
 - Quality Assurance of Clinical Research 

 Business Performances 

As of 15th Jul 2026 

1.Auditing Services (Japan and overseas)

• GCP Investigator Site Audit: 154 (including Industry sponsored Clinical Trials and Investigator-initiated clinical trials)
•  GCP system Audit: 54 (including CRO and IRB etc.)
•  GPSP/GVP Audit: 11
•  Clinical Research: 22 (including Clinical Trial Act)

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

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

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

•  PMDA inspection: 21 
•  Overseas Regulatory inspection: 23 ( FDA, EMA ) 
•  Pre-Inspection Audit: 14
•  Mock inspection: 24

 ４．Educational Training for Clinical Research Professionals

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