GLOBAL CLINICAL STUDY CONSULTATION
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
