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In-Country Caretaker (ICC) services

In-country clinical trial management

The Japan's Pharmaceuticals and Medical Devices Act (PMD Act) stipulates that sponsors who do not reside in Japan and wish to conduct clinical trials in Japan must appoint an In-Country Caretaker (ICC) to request the clinical trials on their behalf.

An In-Country Caretaker (ICC) is a legal representative appointed by a sponsor who does not reside in Japan and who conducts clinical trials in Japan. The In-Country Caretaker (ICC) is stipulated in Article 15 of the Japanese Ministry of Health, Labour and Welfare Ordinance No. 36 (GCP Ordinance), and its responsibilities are defined in the Japanese GCP Guidance.

Micren Healthcare's In-Country Caretaker (ICC) services

Introduction

General Roles and Responsibilities of
an In-Country Caretaker (ICC)

When conducting a clinical trial in Japan, a Clinical Trial Notification (CTN) must be submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) along with the clinical trial protocol and the Investigator’s Brochure (IB). The IB must be written in Japanese and submitted by an In-Country Caretaker (ICC) on behalf of the foreign sponsor.

Sponsors generally require a clinical trial protocol consultation regarding their clinical trial. The purpose of the clinical trial protocol consultation is to obtain PMDA confirmation on the eligibility of study subjects, the number of cases, the validity of endpoints, and the validity of statistical processing methods. Foreign sponsors must have an In-Country Caretaker (ICC) present during the protocol consultation.

Typically, the In-Country Caretaker (ICC) is responsible for the clinical trial and will conduct it in collaboration with a contracted local CRO.

The In-Country Caretaker (ICC) will also be responsible for a wide range of tasks, including the annual review and confirmation of the Investigator’s Brochure (IB), the management of the investigational device, and reporting malfunctions and adverse events to the PMDA.

Japan's clinical trial environment is sophisticated, and conducting clinical trials in compliance with Japan's GCP ordinance is extremely important.

Service

Providing professional and independent
domestic In-Country Caretaker services

Micren Healthcare holds a Type I Marketing Authorization Holder license and also provides services as a Designated Marketing Authorization Holder (DMAH) to foreign manufacturers. In addition to our track record of supporting the operation of clinical trials in Japan as an In-Country Caretaker (ICC), through our activities as a DMAH, we have extensive experience in specialized medical device management and post-market safety management, including adverse event reporting. This experience in DMAH work allows us to fully handle proper customs clearance management, medical device management, malfunction and adverse event reporting, and other GCP-related tasks.

Our goal is to support the conduct of clinical trials in Japan that comply with Japan's GCP Ordinance, and we provide the following services as your In-Country Caretaker (ICC).

Develop and/or review GCP documents, including the Protocol and the Investigator’s Brochure (IB) (including annual reviews and modifications if necessary) in compliance with the Japan GCP Regulation;
Clinical trial protocol consultation support;
Prepare and submit the CTN to the PMDA (including a description of the concerned device, and notification of changes to the relevant parts);
Prepare the agreement with the investigator(s)/institution(s), and support the delivery and management of investigational product(s) to the investigator(s)/institution(s) (in accordance with Article 24 of the Japan GCP Regulation and other applicable regulations);
Report Serious Adverse Events (SAE) to the PMDA;
Prepare and submit the Clinical Trial Report to the PMDA, project management of the clinical trial, including:

Selection of investigator(s)/institution(s);

Obtaining approval from the Institutional Review Board (IRB) (including reviewing and editing documents to be submitted to the IRB);

Management of the CROs selected to implement quality assurance and quality control;
Allow for the use of our In-Country Caretaker’s name and registered address in Japan on your device labels as required;
Access to the office, phone, fax, and mail handling, etc.;

An In-Country Caretaker (ICC) is a key partner in Japan responsible for important regulatory matters. By selecting Micren as your independent In-Country Caretaker (ICC), you can ensure that your clinical trials are properly conducted in compliance with Japan's GCP regulations.