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intellim provides effective resolution to solve various issues related to regulatory affairs

intellim's ICCC Service

intellim takes a responsibility as a sponsor for your clinical trials even if you don’t have your office in Japan.
Our experienced personnel also supports you to find a company for licensing out.

※Definition of Article 15 in GCP
"In order to avoid any occurrence of harm to public health and hygiene with respect to the new investigational drug, and to enable the party to take any necessary actions to prevent such harm from spreading, all parties who do not have a presence in Japan, but wish to conduct clinical trials in this country, shall identify a party who has a presence in Japan, such as a representative of the Japan office of the foreign corporation, that has the capability of requesting clinical trials to be conducted on its behalf, and shall allow said party (hereafter to as the “In-Country Caretaker”) to carry out the necessary procedures relating to the clinical trial."

オンコロジー領域を熟知したチームメンバーによる専門的なサービスを提供いたします

Our Services

Before starting clinical trials

  • Preparation of SOP for operation
  • CRO selection and its reliability check
  • Preparation of Protocol, IP, ICF and other trial documents
  • Clinical Trail Notification (CTN)
  • Site Selection
  • IRB submission

During the trial

  • Review of the progress of the trial with CRO and coordination between you and CRO
  • Collecting and reporting of ADRs

After completion of the trial

  • Preparation of CSR to reporting to you

For more information

If you have any comments, questions, please contact us.

If you have any comments, questions, please contact us.