In-Country Clinical Caretaker (ICCC) Services

In-depth ICCC Experience

CMIC Group acts as an In-Country Clinical Caretaker (ICCC) for overseas sponsors. Individuals who intend to sponsor a clinical trial in Japan, while residing outside of the country shall appoint an ICCC residing in Japan, who is eligible to sponsor the clinical trial on their behalf. When acting as an ICCC in place of the foreign sponsor, CMIC conducts all procedures for regulatory authority, medical institutions, etc., on the foreign sponsor’s behalf. However, the foreign sponsor has final responsibility for the clinical trial.

The fundamental ICCC services are: managing regulatory interactions and safety reporting.

In-Country Clinical Caretaker

Our Edge in In-Country Clinical Caretaker Services

Track record of successful contracted projects from overseas Sponsors

Additional Offerings for Overseas Sponsors

  • Planning of Drug development strategy and Gap Analysis
  • Vendor selection and management (as needed basis)
  • Trial fee payment to clinical sites
  • Labeling and packaging of investigational product

ICCC and Clinical Operation Team Under One Organization

  • Combining our ICCC and clinical trial solutions, we are able to lead foreign companies to conduct their studies with the best speed and quality in Japan.

We have in-depth expertise, with the know-how to face the unique challenges you may have experienced with clinical trials in Japan. Contact our team to learn more.

Services

  • Manage all regulatory interactions with Regulatory Authority (Pre-PMDA meeting, PMDA consultation meeting, CTN submission, NDA submission)
  • Investigational product quality management
  • Safety/pharmacovigilance reporting responsibilities
  • Planning drug development strategy and gap analysis

Marketing Authorization Holder (MAH)

Japan Market Entry

Packaging and Labeling

Clinical Operations

Statistical Analysis

Data Management

Pharmacovigilance

Quality Assurance