University of Tsukuba

Tsukuba Clinical Research& Development Organization(T-CReDO)

Message from the Director
Tsukuba Clinical Research and Development Organization (T-CReDO) was establishedon June 1, 2015 as a result of the collaboration between Faculty of Medicine andUniversity of Tsukuba Hospital.
This organization was a result of positive consolidation and reorganization. It originatesfrom the Clinical Trial and Research Center, Center for Innovative Medicine andEngineering in University Hospital, and Critical Path Research Education Integrated
Leading Center in Faculty of Medicine. The Department of Research and Development
Management and Quality Assurance Office were newly organized for efficientmanagement, and a Council with external and internal members was introduced forgovernance.

Yoshihiro Arakawa, PhD;With experience and function gained from the former organization, we have madeDirector;
Tsukuba Clinical Research andDevelopment Organization (T-CReDO)

progress in clinical development at the University of Tsukuba as well as at the industrygovernment-university research institutes around Tsukuba Science City. We aim todevelop medical seeds and foster researchers and professionals. Without an exit
strategy, medical research results cannot make an effective translation into practicaluse. T-CReDO provides seamless support for practical application of medical seeds andtremendous support in areas concerning intellectual property rights, fund raising, andeducation for entrepreneurs and professional staff in research field.
The University of Tsukuba was selected as one of the Translational and Clinical ResearchCore Centers by Japan Agency for Medical Research and Development (AMED)in March, 2017. T-CReDO promotes medical development to constantly generateinnovative medicines and medical devices, to contribute to public health, to develop the
medical industry, and to serve as an international core center for medical research anddevelopment. Your support in achieving the abovementioned aims and objects will behighly appreciated.

Aiming for the practical application of medical technology by collecting wisdom
we will foster medical seeds, support clinical development, and foster researchers
T-CReDO is centered on the University of Tsukuba and Tsukuba Science City. We collect wisdom from research institutes and develop
research results (seeds) on medical technology and ultimately practically apply the results in fields such as clinical development. We
support the implementation of clinical trials to obtain clinically useful findings. We also encourage young researchers who aim at thedevelopment of medical technology and promote lifelong education and training of researchers involved in clinical research. Throughthese measures, we aim to accelerate the development of innovative pharmaceuticals, medical devices, regenerative medicine, etc.
In addition to contributing to the health and welfare of the people, we aim for sustainable growth and strive to develop international
clinical development bases.
T-CReDO will perform the following tasks to achieve the above mentioned objectives:(1) Clinical development window and consultation (intellectual property, development strategy, etc.)(2) R & D management (pipeline management, planning promotion, finance, etc.)(3) Training medical seeds and promoting open innovation(4) Supporting empirical research aiming for clinical introduction(5) Supporting company-led and doctor-led clinical trials and clinical research(6) Promotion of clinical trial and clinical research network(7) Entrepreneur education(8) Provision of a lifelong education program for clinical researchers and professionals(9) Audit of T-CReDO and individual clinical research(10) Clinical Research Ethics Review Committee, Secretariat Operations of Institutional Review Board, etc.

High Energy Accelerator
Research Organization

Univ. TsukubaMed., Engen., Cybernics,
IIIS, TARA Ctr., Innov. Ctr,,,

High Energy
Accelerator
Res. Org.

Natl. Res. Insts.
(AIST, NIMS,,,)(KEK)

T-CReDO
Bioventures

University of Tsukuba Hospital
T-CReDO

Pharm.
Co.

Tsukuba Station
Kenkyu-gakuen Station

National Institute forMaterials Science

Into PracticeNational Institute for Materials Science
Japan Aerospace Exploration Agency
National Institute of
Biomedical Innovation

Tsukuba-Chuo
Interchange

National Institute of Advanced
Industrial Science and Technology
National Institute of Advanced
Industrial Science and Technology
National Institute for Environmental Studies

Sakura TsuchiuraInterchange

Institute of Physicaland Chemical Research

Tsukuba Junction"Credo" is derived from the Latin word crēdō, which means to believe and signifies
promise, creed, etc. The logo is firm on the ground similar to the Tulip trees along thecampus, signifying the wish to grow richly.

National Agriculture andFood Research Organization
Yatabe Interchange

Tsukuba Ushiku
Interchange

Internal and External Collaborations
1) Fostering medical seeds and supporting clinical development
T-CReDO supports medical seeds and clinical development by collaborating with the University Hospital, Faculty of Medicine, andorganizations inside and outside the university.

Res. Institutes
In Tsukuba Science City●

University of Tsukuba

President

Medical institutions

Natl. Res. Institutes or other Inst.
（AIST, NIMS, NIBIO, RIKEN, KEK, NIAS, etc.),

Seeds

●

Res. Inst. of Pharma, Bio-Venture Co.,

Support●Tsukuba Global Innovation Promotion Agency●

Tsukuba Life Science Innovation Initiative,●

International Strategic Zone●

TIA (Tsukuba Innovation Arena)●

University hospital Clinical Trial Alliance●

Governance,
integrated
operation

Univ. Hosp.

Faculty Med.

Stuff,
Admin.

Faculty
SupportCommittee
MemberCouncil

Headquarters forInternational
Industry-University
Collaboration
Research Administration/
Management OfficeRes. Centers
SupportCollaboration(intellectual property,
industry-academia
collaboration)

Tsukuba Clinical Res. & Dev. Org.
(T-CReDO)

Seeds

University of Tsukuba has signed a comprehensive and collaborative postgraduate agreement with the Pharmaceuticals Medical
Devices Agency (PMDA), which make personal exchanges active.

2) Training researchers and entrepreneurs interested in R & D
We initiated a program, known as Research Studio, for medical entrepreneurs to provide support based on real industry experience.
The program involves the collaboration of experienced researchers and entrepreneurs from Tsukuba and other areas around Tsukuba.
In addition, we have established the lifelong education program for researchers and specialized staff.

Organization
Organizations are classified based on functions and occupations and matrix project management is conducted to enable smoothsupport. TR Promotion and Education Center is responsible for pre-clinical seed development, entrepreneur cultivation, and for
conducting lifelong education programs for researchers. Empirical research and feasibility studies for clinical trials are performed by
the Center for Innovative Medicine and Engineering, and clinical trials are supported by the Clinical Research Service Center.
Director

CouncilConsult. of Develop. Strategy
Univ. Res. Administrators:
Res. Promotion, Pipeline Man.,
IPs, Pub.-Priv. Partnering,
Budget Acquiring, Financial Affairs, Contract,
Secretary for Inside Committees

AdvisorDepartment of R&D Management

Translational Res.
Promotion &Education Center

Center for Innovative
Medicine andEngineering (CIME)

Research Studio(Fostering Entrepreneurs)
Seeds Incubator Tutorial
Consultation in
1) Pre-clinical POC
2) Acquiring IPs
3) Partnering
4) Res. Fund
● Lifetime Education● Cell Processing Factory

Located in Univ. Hosp. Building
1) Feasibility Study of Medical Devices2) Phase 1 study3) Lab. Space●●

Seed Incubation and
Education/Training

Feasibility StudyQA Office
Clinical Research Support Center

Consultation
OfficeGuidance andConsultation to plan
Clinical Trials

Site
Coordinating Unit●●

clinical researchcoordinators (CRCs)
Investigational DrugManagement

CentralCoordinating Unit
Consultation
Operation
Monitoring● Data Management● Biostatistics● Pharmacovigilance

Regional
Network Office● Investigation Review
Regional NW
Natl. Univ. Hosp. Alliance, Board (IRB) Office● Ethics Comm. Office,Public Awareness of● Administration
Clinical Trials● Recruit

●

●

●

●

●

●

Clinical Trials

Seeds Review Committee
Project Review Committee

Admin. OfficeCommittee for Adv. Med. In-house Fund

Seeds Review Committee comprises members with expertise in relevant fields and provides advice, reviews priority of support, and manages projects that involve specific milestones.
Project Review Committee reviews the validity of the use of the space in CIME by the project, in addition to reviewing the validity of support by the Central Coordinating Unit.
Committee for Advanced Medicine In-house fund reviews projects that are part of investigator-initiated clinical trials or advanced medicine to evaluate the utilization of funding.

Introducing Organization
Provides “one-stop service” for medical seed development support

Department of Research and Development Management
Responsibilities:✓Contact point for support provided by T-CReDO for R & D of medical seeds (Collaboration with each department of
T-CReDO and the research promotion and industry-academia collaboration department of the university)✓Progress management at all stages of medical R & D (Pipeline management)✓Consultation service for commercialization of medical seeds (Support for acquiring intellectual property rights andregarding development strategy and regulatory compliance)✓Support for company partnering, obtaining public research funding, etc.

For reliable clinical research and development

Quality Assurance Office

Our goal is to protect the human rights of study subjects and to increase the reliability of clinical trials by verifying
compliance with protocols, SOPs, and regulations, such as the GCP, Clinical Trials ACT, Ethical Guidelines for Medical and
Health Research Involving Human Subjects, and the Declaration of Helsinki from an objective standpoint. We also support
medical institutions and trial sites in system audits by evaluating design and performance of the computer system.
These activities support to increase the reliability of clinical trials.

Educational platform for taking scientific achievements to the bedside

Translational Research Promotion and Education Center
1) Research Studio (Entrepreneurship course) is an acceleration program for clinical scientists, basic scientists, and young
entrepreneurs who are willing to launch or join startup companies in the healthcare field based on their academic
research achievements. The course provides basic knowledge regarding the preparation of a target product profile(TPP), sharing the image of the final product with internal and external stakeholders, and generation of a road map of
product development with a proper fund-raising plan under the supervision of professional mentors from local institutes,
venture capitalists, senior entrepreneurs, and other international partners.
2) Seeds Incubator is a system that provides advice regarding non-clinical testing, intellectual properties, collaboration,
fundraising, etc., to scientists who perform research and aim to conduct clinical trials.
3) Lifetime Education for Scientists and Professionals, provided by the center, is based on their occupations andpositions. We provide Clinical Research courses for Principal Investigators, Data Managers, Monitors, and CRCs, as wellas Business Strategy and Regulatory Science courses for professionals in the drug and medical device development
field. We supervise the translational research thesis work of graduate students in the Master’s Program in Medical
Sciences and provide on-the-job training regarding clinical research support, clinical data management, and CRC.
The comprehensive alliance between the University of Tsukuba and PMDA, including the HR exchange or the linked
graduate school system, provide exposure to graduate students with respect to real regulatory affairs work.
4) Cell Processing Factory (CPF) manages the operation of the cell processing facility and supports researches in thefield of tissue and cell therapy.

Seamless support for clinical development and clinical trial

Clinical Research Support Center

The Clinical Research Support Center is responsible for supporting clinical trials and clinical studies. It comprises several
units and offices with the following diverse functions:
Central Coordinating Unit co-ordinates clinical trials and acts as a data center.
Site Management Unit provides on-site support for clinical trials and clinical studies conducted in the University Hospital.
Regional Network Office maintains a network of regional medical institutions for better case accumulation.
Consultation Office provides support for the planning of clinical studies.
Administration Office manages the IRB and the Ethics Committee
The center has a matrix management scheme based on both functions and projects to provide seamless help.

Reliable project management and high-quality data collection and analysis.

Central Coordinating Unit

The Central Coordinating Unit, in association with other departments, conducts various clinical trials,
including nationwide multicenter, single-facility, or investigator-initiated clinical trials. Our services
are diverse, for example, we provide advice regarding development strategy and protocol writing by
experienced staff with R & D expertise in pharmaceuticals, data management using the electronic data capture (EDC) system,
central and on-site monitoring, and statistical analysis by biostatisticians. We enhance the credibility of high-quality clinicaldata and data analysis based on our experience of managing more than 70 projects.

We support researchers in the planning of their clinical trials.

Consultation Office

We support researchers in the planning of their clinical research under the Clinical Trials Act or Ethical Guidelines for
Medical and Health Research Involving Human Subjects. We aim to clarify their clinical questions, hypotheses, and PICO
questions. We advise researchers regarding a variety of subjects, including research design, end-point, optimal sample
size, etc. We also collaborate with other units of T-CReDO considering exit strategies with respect to the quality of researchand the applicable regulatory requirements.

Individual-oriented on-site coordination for trial

Site Coordinating Unit

To cope with the diversification of clinical trials and clinical studies, experienced CRCs prepare to present
the trial before the IRB and communicate closely with clients, support subjects, and investigators toensure smooth implementation of the trial. Our management of test drugs or information is strict enoughfor global trials or complicated protocols. We also handle serious adverse event (SAE) reports.
Collaboration and information sharing with the Central Coordinating Unit and other departments of
T-CReDO makes our support more practical.

Introducing Organization
It is based on reliability, speed, and efficiency

Administration Office

As the Secretariat of the Institutional Review Board and the Clinical Research Ethics Review Committee,
the Administration Office is responsible for organizing work and research ethics workshops, in addition
to managing the general affairs of other departments. We perform collective duties and work hard
to manage the organization. During clinical trials, we consistently perform administrative procedures
including feasibility studies and contract.
With respect to clinical research, we conduct ethical review procedures and store management of reports. We respondflexibly to requests on the trial from the sponsor and researchers, coordinate with each department efficiently, and support
the operation of clinical trial.

High-quality clinical research with efficiency and information sharing

Regional Network Office

Networking among medical institutes is essential for development of pharmaceuticals andmedical devices. Regional networks, such as the Clinical Trial & Research Network IBARAKI,
which has core hospitals in the area, and the University Hospitals Alliance, make trials effective
and enhance the quality of clinical research by information sharing. We handle feasibility studies,
central IRB operations, and progress management as a whole. We also reach out to citizens toencourage them to participate in the clinical trials and research.

Realization of innovative medicine through collaboration of state-of-the-art science

Center for Innovative Medicine and Engineering

We promote clinical development of medicine and medical devices through interdisciplinary researchsuch as medicine and engineering collaboration. Located in the University Hospital building, our center
gives researchers from outside an easy access to the study site and helps them to contact on-site
researchers and medical staff who can take care of patients easily. To meet the wide range of study
requirements, we have studios and rooms on rent, which can be used to reproduce the patients’ room
environments. In addition, we also have various instruments, such as those for image analysis including
devices for motion-capture.
We have supported several collaborative researches by the university, industry, and research institutes.
We also help researchers contact relevant departments in the university and university hospital.

Researches we promote

Endowed Courses: Clinical Research and Regional Innovation, Universityof Tsukuba, Faculty of medicine, etc.
We have our own clinical researches in practice. Collaborating with researchers inside and outside the university andindustry, we promote research conducted for searching seeds, clinical research for prevention of life-style related diseases,
and practical studies on effective clinical development and medical treatment. One such fields is the JA IBARAKI supported
Regional Clinical Research Innovation.

JapanTsukuba

University of Tsukuba Hospital

T-CReDO

Tsukubadaigakubyouiniriguchi
Bus Stop

Hospital Bus Stop
Tsukuba Medical
Center Hospital
Kasuga1-Chome Nishi

Matsumi Park

Tsukuba Express

Tsukuba Expo Center
Tsukuba
StationCreo
Square

Saiki
Higashi Odori

Nishi Odori

Akihabara
StationKita Odori

Chuo-dori
Tsukuba Center
Tsuchiura Gakuensen

Gakuen Higashi

From Tsukuba Express (TX)
45 minutes fast from Akihabara station to Tsukuba station
From Tsukuba Center
About 5 minutes by bus
From the Highway
About 10 minutes by car from Tsukuba-Chuo I.C.

Tsukuba Clinical & Development Organization
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576 Japan
Within University of Tsukuba Hospital
Phone number +81-29-853-3914

http://www.s.hosp.tsukuba.ac.jp/t-credo

June 2019