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HOME  > Department of Clinical Research Promotion

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

Salutation

Thanks to the support and the understanding from everybody involved, in Yokohama City and elsewhere, we have established the Yokohama City University Center for Novel and Exploratory Clinical Trials (Y-NEXT) in April 2015.
This Center, Y-NEXT for short, has been so named with the desire to deliver cutting-edge treatment to all citizens of Yokohama and beyond who suffer from diseases, by promoting the development of those treatments that will form “the next step.”
To promote clinical trials and clinical research in collaboration with regional healthcare facilities, we have appointed specialists including statistics experts, data managers, and clinical research coordinators with based on the support of Yokohama City, and aim for an early designation as a “Clinical Trials Core Hospital” under the Medical Care Act of April 2015.
Furthermore, we provide a clinical research network with the Yokohama City University Hospital at its core, as well as 20 beds for Phase I clinical trials for which the regulations of the National Strategic Special Zones have been relaxed.
With these, the Y-NEXT aims to increase efficiency, speed and quality in its research, and implement initiatives for feeding back research outcomes at an early stage, including development of innovative drugs and advanced treatments. We as a university will put all our efforts into this and would like to ask you all for your support and collaboration.

Director
Professor, Graduate School of Medicinee
HIRAYASU Yoshio

Organization Chart

Clinical Research Coordination Dept.

Clinical trials require ethical and scientific implementation according to“Good Clinical Practice”, a standard for the implementation of clinical trials for pharmaceuticals, or the “ethical guidelines for medical studies with human subjects.” The Clinical Research Coordination Dept. fulfils 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 investigational 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.
Dept. Head
Prof. TERAUCHI Yasuo

Clinical Research Support Dept.

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.

Datacenter

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’ 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.

Dept. Head
Prof. YAMANAKA Takeharu

Reliability Assurance Dept. (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.
Dept. Head
Prof. ITO Shuichi

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” 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.
Dept. Head
Prof. ORIDATE Nobuhiko

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