Pursuant to Japanese GCP Article 15, in order for a company without a Japanese subsidiary (“Foreign Sponsor”) to conduct a clinical trial with an investigational new drug in Japan, it is required that the Foreign Sponsor designate a third party incorporated in Japan as a Clinical Trial In-Country Caretaker (CT-ICC) who jointly undertakes the legal, regulatory, and operational obligations of the Foreign Sponsor.

• Filing and maintenance of Clinical Trials Notifications (CTNs)
• Management of all regulatory interactions with PMDA and MHLW on behalf of the Sponsor
• Assumption of all safety/pharmacovigilance reporting responsibilities
• Management of IP & Clinical Supply importation procedures
• Overall responsibility for quality aspects of the clinical study