Kanagawa Accademy of Science and Technology
Global Health Research Coordinating Center (GHRCC)
Directer: Mr.Masaki Ikeda
Investigation period: 2015〜2020
Laboratory members:
・Study Cordenater(SC)
・Clinical Reserch Associate(CRA)
・Office Personnel

By combining Patient, Family and Community with knowledge obtained by conducting clinical researches,
we contribute to the development of health care and healthy life of people around the world.

Basic principle

I. Management support of clinical research

Our primary support areas are “rare cancer”, “pediatric cancer”, “mental/incurable neurological disease” and “regenerative medicine” and we comprehensively support clinical trials and clinical studies initiated by domestic and international academia and industries beyond the boundaries of universities and medical institutions.

II. Promotion of global clinical research

We perform educational activities to increase motivation of researchers and medical staffs for participation in global clinical researches.

III. Dissemination of knowledge and address to diseases which are at the pre-symptomatic state

Based on clinical data, we conduct activities to disseminate general ideas and the importance of diseases which are at the pre-symptomatic state.

IV. Consultation on clinical research

We provide consultation on developmental strategies, research implementation systems, etc. of seeds(new drugs, extension of indications, diagnostic reagents, medical devices, food)originated in academia and industries from the “practical aspect”.

V. Development of human resources specialized in clinical research

We aim to increase human resources currently needed, such as research nurses*1 and research assistants*2, for the achievement of high quality research.

*1 Nurses who are able to manage clinical research in a routine medical care.
*2 Research assistants who have received basic education, protocol education and internship, and can support tasks such as data management after being dispatched to research institutions

 

Contents of supporting operation


Business support for researcher/research client and coordination between research organizations
-Research planning and preparation support
-Study schedule management
-Document preparation support
-Study protocol/informed consent form(English/Japanese)
-Standard operating procedure(SOP)
-Various applications (clinical trial application, advanced medicine applications, etc.)
-Various reports(clinical study report, etc.)
Support for participating medical institutions                     
Support for case registration(establishment of case registration center, progress management, promotion of case registration)
Support for conducting an adequate trial implementation(central monitoring and prevention of deviation, etc.)
Support for holding various committees(Data and safety monitoring committee, Monitoring committee, etc.)
Safety information management
Support for handling trial drugs
Support for responding to regulatory agents(strategic consultation of pharmaceutical affairs and face to face advice, compliance document analysis, GCP compliance, etc.)
 
Addition to coordination mentioned above;
Communication with research groups in each country/ inquiry desk
Support for procedures from preparing a contract to obtaining a contract agreement
Support for procedures in accordance with regulatory guidelines in each country
Support for procedures involving import of study drugs
Support for addressing overseas audits
 
Quality management regarding GHRCC entrustment
Management of Standard operating procedure(SOP), research plans and various reports
Conducting central monitoring/onsite monitoring
Support for conducting audits in medical institutions
Consultation and advice on developmental strategy of seeds originated in academia/industry to
increase the feasibility
Consultation and advice on maintaining a clinical research implementation system

Accepting research students and visitors
Training personnel specialized in clinical research
Organizing seminars related to clinical research
Collecting and releasing information related to global clinical research
Dissemination of accurate information regarding clinical research

Achievement(April, 2015 ~September, 2015)

Currently, we have contracted supporting operations of 6 clinical researches and are conducting 23 consultations.
 Details of contracted clinical research
◆ Investigator-Initiated Indication-Directed Clinical Trials (including 3 multi-center international studies)
  5 trials: pediatric cancer(1), rare cancer(1), incurable disease(3)
◆ Investigator-Initiated Clinical Trials(including 1 multi-center international study)
  1 trial: rare cancer (1)