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.

As a CT-ICC, IDA can undertake the following responsibilities on behalf of its clients:

  • 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
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