About "TQAN"
TQAN provides General Consulting, Quality Assurance and Educational services for your clinical research.
Services
1．Auditing (Japan and overseas)
2．Consulting on planning and implementation of clinical trials and Clinical Researches
3．Regulatory Inspection Readiness
4．Educational Training for Clinical Research Professionals
Organization
| Business name | Tutti Quality Assurance Network (TQAN) |
| Business form | Sole proprietorship |
| Business start date | April 1, 2020 |
| President | Naoki Tsutsumi |
| Location | 171 Okura, Momoyamacho, Fushimi Ward, Kyoto City, Kyoto Prefecture |
Business performances
(as of 28 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
Introduction of the president
President
NAOKI TSUTSUMI. Ph. D.
PROFILE
Work Experience：
1990 – 2011 Bayer Yakuhin 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
Industry Activity / Membership：
2010 - Present Pocket Handbook(Multinational Clinical Trials), Editorial Committee
2012 - 2023 Association of Clinical Research Professionals (ACRP) Japan, Board Member
2013 - 2018 Association of Clinical Research Professionals (ACRP), Global Exam Committee
2016 - Present PharmaTrain SMD, National PharmaTrain Certification Board Member
2018 - Present Japan Society of Quality Assurance (JSQA), Member
2018 - Present Research Quality Assurance (RQA), Member
2015 - 2022 Association of Clinical Research Professionals (ACRP), Board of Trustees
2020 - Present Director, Japan Institute for Public Engagement Board Member
2021 - Present Clinical Trial Promotion Foundation, Councilor
2023 - Present Society of Quality Assurance (SQA), Member
Certification：
2008 - present CCRA Association of Clinical Research Professionals (ACRP)
Education：
1990 Graduate School of Agriculture, Kyoto Prefectural University, Master of Agriculture
2022 Graduate School of Pharmaceutical Sciences, The University of Tokyo, Doctor of Pharmaceutical Sciences
Publication：
2022 Study on Quality and Efficiency of Ethical Review and Audits Using ICT (Doctoral Dissertation), The university of Tokyo
2021 A group of Patient Public Involvement (PPI) shared their feelings after reading“DECLARATION OF HELSINKI
“, Part 1 - 3 (co-author).Clinical Evaluation
2021 Guiding Principles on Reasonable Agreements between Patient Advocates and Pharmaceutical Companies (co-author). Clinical Evaluation
2021 A Study on a Strategic Model to Implement Remote Auditing, Clinical Evaluation
2021 Remote review practices of IRBs during the COVID-19 pandemic in Korea: comparison with a Japanese study. Translational and Regulatory Sciences
2010 – 2020 Annual contributions / co-authoring of Pocket Handbook for Multinational Clinical Trials. Pocket Handbook Editorial Committee
2020 Utilization of Information and Communication Technology in IRBs as a Countermeasure Against the COVID-19 Outbreak and Future Challenges. Clinical Evaluation
2020 The Future of Medicines Development and the Professional Development for Public Engagement (co-author). Clinical Evaluation
2018 Guidance for GCP Audits for Academia and Pharmaceutical Companies (co-author), Medical Publications Co., Ltd.
2016 Quality Control and Quality Assurance in Pediatric Clinical Research (co-author), Iyaku (Medicine and Drug) Journal Co., Ltd.
2015 GCP Audits by Pharmaceutical Companies (co-author), Medical ublications Co., Ltd.
2015 Trends of Findings in GCP Inspections by FDA, EMA and PMDA, Science and Technology Co., Ltd.
2015 Protocol Deviations in Multinational Clinical Trials (co-author), Medical Publications Co., Ltd
2011 GCP Inspection by FDA (co-author), JOHOKIKO Co., Ltd.