We offer the following consulting and operational services to pharmaceutical, biotechnology, and academic organizations:

• Project management for Investigator Initiated CT (IICT) for Registration
• Your in-country care taker (like a representative office in Japan)
• Overall Japan development strategy including regulatory strategies/path evaluation
• Clinical development strategy and planning, Clinical plan and clinical protocol conceptualization and creation/writing, FIH study planning and coordination with clinical trial centers in Japan
• Design and create procedures for clinical endpoint evaluation/adjudication process and manage committee meeting and related events.
• Key opinion leader engagement plan/support, including identification of, and interaction with, potential investigators and academic-/industry wide leaders
• Organization and management of expert meeting/advisory board meetings
• Clinical development operating planning and execution (CRO evaluation, selection, liaison, management/trial oversight)
• Participation in regulatory authority meetings and related interactions
• Participation in cross-functional drug development teams
• Scientific/regulatory and technical evaluation of new projects, in-license candidates, business development opportunities
• Strategic and development advisory services (e.g., how to apply new technologies (medical big data etc) into clinical development and businesses) to senior level management