Providing Project Management of Clinical Examinations and Trials
The HTR has supported seeds research projects through the total project administration support, the Department of TR Planning and Management supports researchers with consultation on ways to proceed with seeds research, helping to organize and evaluate non-clinical test data etc.
Click here to see the HTR assistance structure.
Non-clinical Trials – Clinical Trials
Project Management
Identify problems in the research, planning of development strategies, and progress management
Oversight of intellectual property information
Provide support for prior-art searches, patent applications, and contract with outside companies
Support for the conduct of non-clinical trials
Enable speedy clinical development and licensing-out by assisting clinical trial planning for non-clinical trials in the development of “medications” and “medical device” (efficacy, safety, and manufacture of medicines), and assist in fulfilling scientific and regulation requirements
Support in pharmaceutical strategy consultations with PMDA
Support in matters related to pharmaceutical strategy consultation with the Pharmaceuticals and Medical Devices Evaluation Agency (PMDA), and compiling supporting data
Ensuring quality of experimental equipment
Provide support for development of “medications” and “medical equipment”, and establishing frameworks for investigations with new drugs (experimental data) in accordance with Good Manufacturing Practice (GMP/QMS) standards
Support with Intellectual Property and Contract Issues
Intellectual Property Issues
- Patent information searches related to the Seeds Research projects of individuals
- Prior-art search
- Information about business organizations and market research
Contracts
- Support in concluding confidentiality agreements with (prospective) joint development partners
- Support in concluding material transfer agreements (MTA) with (prospective) joint development partners
- Support in concluding joint development agreements with joint development partners
(arrangements related to intellectual property rights, allocation of research funds, and pricing decisions when making products commercially available)
Consultations to Speed Up Research and Apply for Research Funds
- Research and development planning through discussion with researchers
- Mapping out strategies based on PMDA consultations and acceleration of development
- Arrangement of outsourcing of safety tests and evaluation of conformity with Good Laboratory Practice (GLP)
- Consultation related to production of active pharmaceutical ingredients and investigation of new drugs, establishment of frameworks to meet GMP standards for investigation of new drugs and quality assessments, as well as arrangement of outsourcing
- Comprehensive evaluation of research activities and measures required to initiate clinical trials
- Consultation and support to apply for research funds
Assist in Matching with Potential Collaborating Parties/Search for and Investigation of Companies that May Be Interested in Collaborating in Research and Development
