GLOBAL CLINICAL STUDY CONSULTATION
The Department of International trials (DIT) is a part of the Center for Clinical Sciences (CCS) at the National Center for Global Health and Medicine (NCGM). Its main mission is to contribute to global health by facilitating Multi-Regional Clinical Trials (MRCTs) or other forms of clinical research in Emerging and Re-emerging infectious Diseases, Noncommunicable Diseases, Neglected and Rare Diseases, and lifestyle practices. Furthermore, DIT places personal internationally to further accelerate networks with public organizations in partner countries. We welcome various organizations including Japanese medical companies, academia, research institutes, etc., that share the same mission and want to collaborate.
Instruction:
This form is provided for applicants who are interested to collaborate or to request DIT's assistance/consultation in the areas of MRCTs or other kinds of clinical research. Please complete this application form as accurately as possible. The organization being represented should be aware of and agree to the information provided. Information will be treated as confidential per non-disclosure/confidentiality agreement, with emphasis on respecting intellectual property or proprietary information, retroactive to the date of submission of this application.
CONSULTATION EXAMPLES
Consultation examples are as follow (but not limited to):
- Consultation on strategies for international expansion.
- Support negotiations with regulatory authorities in the countries concerned including securing access to the regulatory consultations.
- Support and/or coordinate the work with respective stakeholders including 厚労省, PMDA*, JICA**, Embassies in the country/ies concerned.
- Support execution of clinical/clinical pharmacology studies including protocol design, statistical analysis plan and the analysis, project management, etc.
- Support and/or coordinate designing of innovative clinical research.
- Support information-gathering related to establish infrastructures in the countries concerned.
- Support and/or coordinate enhanced capacity-building.
- Support to secure financial resources to conduct clinical research in the countries concerned.
- Support and/or provide consultations on risk-management-related matters (such as in cultural and/or political facets).
For a consultation request please click here or click the button at the bottom of the page
* Pharmaceuticals and Medical Devices Agency ** Japan International Cooperation Agency
