In Country Clinical Caretaker (ICCC) for Clinical Trials in Japan

In-Country Clinical Caretaker Services (ICCC)drsadmin2025-05-15T14:46:18-04:00

In-Country Clinical Caretaker (ICCC) Services

What are In-County Clinical Caretaker (ICCC) Services?

At CMIC Group, we can act 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.

JCROA (Japan CRO Association) defines ICCC as below:

“In order to take the necessary measures to prevent the occurrence or spread of health hazards due to drugs used in the clinical trial, a person who intends to sponsor a clinical trial and resides outside Japan shall appoint a person eligible for sponsoring the clinical trial on behalf of the person who intends to sponsor a clinical trial from among persons residing in Japan (including the head of a Japanese business office of a foreign company) to have him or her (hereinafter referred to as “Clinical Trial In-Country Representative*”) conduct the procedures for sponsoring the clinical trial (J-GCP Article 15). *: Clinical Trial In-Country Representative is referred to as an In-country Clinical Caretaker (ICCC) in this document.”

Reference: https://www.jcroa.or.jp/english/essential-considerations-for-iccc/

In-Country Clinical Caretaker Representatives CMIC Group

Our Edge in In-Country Clinical Caretaker Services

Track record of successful contracted projects from overseas Sponsors

In-Country Clinical Caretaker CMIC Leading Studies

Wealth of Knowledge and Experience for In-Country Clinical Caretaker Services (ICCC)

– With the highest number of ICCC trials conducted among domestic CROs in Japan (67 trials in the past five years) and 30+ years of experience, we ensure your trial runs smoothly and deliver high-quality results.
– At CMIC, we have a diverse team of professionals with expertise across a wide range of disciplines. This allows us to assemble customized teams tailored to the specific needs of each clinical trial and client. Each department at CMIC draws on deep knowledge and experience to support the seamless execution of clinical trials. Our services include regulatory consultation, identifying the fastest path to trial initiation, accelerating patient enrollment, issue management, and more.

Leading Experts in Regulatory Consultation

– CMIC’s highly experienced consulting team offers flexibility to respond to each individual project, supporting our overseas sponsors.
– Our accompanying consulting services have been well received by our clients, and we have conducted 142 PMDA consultations in the past five years.
– Examples of our services include:

Gap analysis with Japanese regulatory requirements
PMDA consultation support
Preparation of CTD (Common Technical Document) including CMC module
Strategy development for NHI price
Orphan Drug Designation (ODD) and Cartagena application support

Strong Site and KOL Connection

– Fostering strong relationships with Key Opinion Leaders (KOLs) is crucial for successful clinical trials in Japan (e.g., drug development strategies, site selection, patient enrollment, etc.).

Established relationships with clinical trial sites and investigators over the past 30+ years
Connections with over 4,000 clinical trial sites in Asia-Pacific region.
Strong relationships with KOLs in various therapeutic areas
Established advisory agreements , enabling us to introduce Japanese KOLs and propose the most suitable trial implementation plans based on the specific medical environments in Japan

Leading Sponsors Through Inspections

– CMIC has continuously improved the quality of our services, resulting in zero major findings during inspections, including those by overseas regulatory authorities, over the past five years.
– Guiding sponsors based on their specific needs and requirements:

Conduct operations with a view towards inspections from the start-up phase of the trial by leveraging our experience and knowledge
Provide instructions on necessary documentation and timelines
Provide advice based on PMDA’s question trends
Conduct mock inspections
Maintaining close communication with PMDA to negotiate and/or obtain information in a timely manner