YCU Center for Novel and Exploratory Clinical Trials (Y-NEXT)

By supporting research at multiple levels, the Department of Research & Development promotes a number of projects that will lead to the development of new methods for prevention, diagnosis and treatment of socially significant illnesses such as cancer and lifestyle-related diseases. These projects, which will translate important research results in basic medical science into medical technologies to be applied in clinical practices, are referred to as Translational Research (TR). These TR projects will enable medical providers to promptly provide advanced care, and facilitate local development by introducing new medical care-related life science industry to this region.

Through this work, we are exerting our utmost efforts to help improve the health of the citizens of Yokohama City. We greatly appreciate your understanding and assistance.

Michiko Aihara

Director, YCU Center for Novel and Exploratory Clinical Trials

Prof. Yasuo Terauchi

Department Head

Clinical Research Coordination Department

Clinical trials require ethical and scientific implementation according to Good Clinical Practices, a standard for the implementation of clinical trials for pharmaceuticals, or the ethical guidelines for medical studies with human subjects.h The Clinical Research Coordination Dept. fulfills an important role as Clinical Research Coordinator, supporting physicians and subjects to ensure that trials can be implemented smoothly and properly. It also plays an important role in the proper management of investigatory drugs and clinical trial administration.

Furthermore, it also plans to proactively expand independent clinical trial CRC work to meet medical needs in relation to post-marketing pharmaceuticals, medical devices, or surgical techniques. The department aims to play a role in the provision of clinical trials by Yokohama City University by improving clinical trial quality throughout the university.

Prof. Takeharu Yamanaka

Department Head

Clinical Research Support Department

Since the execution of clinical trials involves a great many people, from patients to physicians and staff from the datacenter, as well as participating facilities and administrative depts., it requires a point of view where individual trials are managed and their progress monitored as single projects. The Clinical Research Support Dept. has a coordinating role in providing integrated support that includes all Y-NEXT functions(datacenter/CRC/audit/management center etc.), performing research project management relating to multiple institutions, working on contracts with participating institutions, etc. The Department will appoint fulltime physicians and pharmacists, and to expand its active support in protocol review and protocol creation from the perspective of medical specialists, who are well informed about clinical trials, and specialists with experience of regulatory agencies, and in drawing up a development roadmap for the application of investigator-initiated trials.


Securing the quality of data on efficacy and adverse events in clinical trials is linked to securing the reliability of research outcomes and ensuring trial subjectsf safety. The Y-NEXT Datacenter introduces a clinical trial data management system (CDMS), which takes account of ICH-GCP, including audit trails. It further aims to spread the method of risk-based monitoring in academia trials that combines central monitoring and sampling SDV. Statistical analysis is supported by Yokohama City University's team of biostatistics experts, which boasts of the best line-up in nation-wide academia. They will lead clinical researchers in the acquisition of accurate answers from clinical trials that take long time period.

Prof. Shuichi Ito

Department Head

Reliability Assurance Department (Audits)

While monitoring takes care of Quality Control during clinical trials, audits are for the purpose of Quality Assurance of the overall trial, including its monitoring. It guarantees the reliability of research outcomes and the morality towards participating subjects by confirming whether a clinical trial is conducted according to its planning, and whether it is conducted in line with GCP or clinical trial guidelines.

We also plans to introduce mutual audits between researchers, and aims to further improve the quality of multi-center studies conducted within the Yokohama Clinical Research Network.

Prof. Nobuhiko Oridate

Department Head

Advanced Medical Promotion Center

The Advanced Medical Promotion Center was established to develop new healthcare technologies originated in YCU, aiming to be approved by the Ministry of Labour, Health and Welfare (MLHW). This could lead to the promotion of public healthcare in Yokohama City by providing high-grade treatment modalities in YCU.

The Advanced Medical Promotion Projecth has been started to fulfill the aim. This project supports inspections of the applied proposals by the Review Board, as well as progress assessments and follow-ups of the accepted proposals. At the end of March 2015, seven proposals have been approved by the MLHW as advanced healthcare modalities The Cell Processing Center provides specialized technical supports to the proposals related to regenerative medicine.