Organization

Organization & Staff

JCRAC supports data management for clinical research through its two offices, the Office of Clinical Data Management and the Office of Bioinformatics.

Structure

Organizational Structure

Department of Joint Center for Researchers, Associates and Clinicians (JCRAC)

Director: Hajime Ohyanagi

Office of Clinical Data Management

To ensure the reliability and quality of research results, we conduct data management in a scientific and logical manner, managing not only outcomes but also processes. The office is responsible for study protocol and CRF development, EDC setup, participant registration and allocation management, and data management operations. We have established a quality assurance system based on ISO 9001 and introduced a PDCA cycle to continually maintain and improve the quality of our products and services.

Office of Bioinformatics

The office operates and manages our on-premises EDC systems (REDCap and Da Capo) and the IT infrastructure, including departmental PCs and networks. While developing and maintaining an information security management system (ISMS) based on ISO/IEC 27001, it also pursues its own research on genome and omics studies using bioinformatics technologies and on applying AI technologies to data management operations.

History

Since its establishment, JCRAC has operated under the guidance of a group of researchers at the National Center for Global Health and Medicine (NCGM, now the Japan Institute for Health Security, JIHS).

2001

Founded as the Japan Clinical Research Data Center within the Society of Japanese Pharmacopoeia (now the Pharmaceutical and Medical Device Regulatory Science Society of Japan, PMRJ) as part of the Millennium Project, under the name JCRAC (Japan Clinical Research Assist Center).
2006

Moved its organizational base to the Japan Foundation for the Promotion of International Medical Research Cooperation (dissolved on July 1, 2013) and continued operations as JCRAC.
2011

Operations were transferred to the Center for Clinical Sciences, NCGM, and JCRAC was relaunched as the Joint Center for Researchers, Associates and Clinicians.
2023

Reorganized and strengthened as JCRAC, comprising two offices: the Office of Clinical Data Management and the Office of Bioinformatics.

Members

Our Staff

Director & Managers

Hajime Ohyanagi

Director, Department of Joint Center for Researchers, Associates and Clinicians (JCRAC), Center for Clinical Sciences

Career: Graduated from the Faculty of Agriculture, The University of Tokyo (1996); completed the master's program at the Graduate School of Agricultural and Life Sciences, The University of Tokyo (1999); Ph.D. by dissertation from the School of Life Science, SOKENDAI (The Graduate University for Advanced Studies) (2009). After working at Mitsubishi Space Software Co., Ltd. (Leading Engineer / Chief Researcher, 1999–2015) and King Abdullah University of Science and Technology (KAUST), Saudi Arabia (Research Specialist, 2015–2021), he assumed his current position in September 2021. He also serves as a visiting researcher at Meiji University and a part-time lecturer at Maebashi Institute of Technology, among other roles.
Degree: Ph.D. in Science (Genetics)
Fields of Expertise: Molecular evolution, population genomics, bioinformatics, biological databases, and systems engineering
Journals & Societies: Editor of the database special issues of Plant & Cell Physiology (2014–2018); steering committee member of the Japanese Society for Plant Informatics (2018–present)
Certifications: IT Service Manager Examination, Information Security Administrator, Network Specialist Examination, etc. (IPA national examinations, including qualifications obtained under former examination names)

Main Activities

Specializes in the molecular evolution of microorganisms, plants, and animals based on large-scale genome information. Having devoted much of his career to plant genome analysis, he served for many years as a journal editor and is recognized as a leading expert in plant databases. At the Japan Institute for Health Security, he applies his knowledge and experience in genome analysis to the study of the molecular and genomic evolution of viruses. Drawing also on his expertise in systems engineering from the first half of his career, he oversees and advances clinical research data management at JCRAC as well as registry-related information projects, including iCROWN (Infectious Disease Clinical Research Network with National Repository).

Koji Kitajima

Manager, Office of Clinical Data Management

Career: Graduated from Kagawa University (1992). Engaged in the development and operation of medical billing systems and order entry (CPOE) and electronic medical record (EMR) systems at a local computer center. From 2007, drawing on his knowledge of medical informatics, he supported the contracted development of the EDC system INDICE at the UMIN Center, The University of Tokyo, before assuming his current position in April 2017.

Main Activities

Drawing on his knowledge of medical informatics and his experience in building EDC systems, he handles the system design of Da Capo and, as the EDC system administrator, manages overall system configuration. In addition to working as a data manager, he has been active for 18 years in a working group as a member of the CDISC Japan User Group. For studies contracted to JCRAC, he is responsible end to end, from first contact through quotation and contracting, oversees overall project management, and, as the quality control manager, not only meets quality requirements but also pursues continual improvement.

Yuichi Kawanishi

Manager, Office of Bioinformatics

Career: Graduated from the Faculty of Science, Kyushu University (1989); completed the master's program at the Graduate School of Science, Kyushu University (1991); Ph.D. in Agriculture by dissertation from the Graduate School of Bioresource and Bioenvironmental Sciences, Kyushu University (2009). After working at Fujitsu Limited, the University of the Ryukyus, Hamamatsu University School of Medicine, and SRL, Inc., he assumed his current position in July 2023.
Fields of Expertise: Molecular evolution, bioinformatics
Certifications: Certified Information Technology Engineer, Application Systems Engineer (IPA, former examination name), etc.

Main Activities

Works on identifying disease-related genes through genome analysis, drawing on his knowledge, skills, and experience in bioinformatics and molecular evolution. He also draws on his experience as an IT engineer to promote information security and to apply AI technologies to data management operations.

Department of Joint Center for Researchers, Associates and Clinicians (JCRAC)

Clinical Secretary

Mie Sakamoto

Clinical Data Manager

Mami Shimazaki

Office of Clinical Data Management

Senior Researcher (Principal Clinical Data Manager)

Tomoko Iwamoto

Senior Researcher (Principal Clinical Data Manager)

Masashi Fujimoto

Technical Official (Senior Clinical Data Manager)

Yasuharu Sasaki

Specially Appointed Researcher (Senior Clinical Data Manager)

Akemi Yasuhara

Specially Appointed Researcher (Senior Clinical Data Manager)

Keiko Fujimura

Specially Appointed Researcher (Senior Clinical Data Manager)

Chitose Oda

Clinical Data Manager

Mariko Tateo

Clinical Data Manager

Ryoko Taki

Clinical Data Manager

Chiyoko Toyama

Office of Bioinformatics

Senior Researcher

Saya Ohi

Senior Researcher

Daiki Ikeda

Systems Engineer

Hiroshi Ikawa

Systems Engineer

Takahiro Sakurai

Consultations & Inquiries

We welcome inquiries about data management for clinical research.