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In-Country Clinical Caretaker

2022.08.01

In-Country Clinical Caretaker

Contract management work for a full scope of clinical trials, as a representative for overseas clients

In-Country Clinical Caretaker

Befor starting clinical trials

Preparation of SOP for clinical trials
Consulting and support for Japanese regulations
CRO selection and assessing its reliability
Preparation of Protocol, IB, ICF and other clinical trial documents
Selection of PI and institutions
Submission of Clinical Trial Notification (CTN)
IRB submission

During the trial

Monitoring study progress of the clinical trial
Verification of compliance to GCP and protocol
Gathering, provision and management of safety information

After completion of the trial

CSR preparation and its reporting

関連ページ(Related Pages)

ICCC(治験国内管理人)

ICCC(治験国内管理人)

ICCC (In-Country Clinical Caretaker)

ICCC (In-Country Clinical Caretaker)

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