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Central IRB

Administrative Service for Central IRB (single IRB)

EP-SOGO supports management of central IRB established in our partner sites. In addition, EP-SOGO has also supported Certified Committees for Regenerative Medicine since 2017. Not only full SMO service package for medicines and medical devices, EP-SOGO can also provide single service of IRB or reviews for regenerative therapy. For further information, please feel free to contact us.


*Central IRB:IRB set up at a certain site that undertakes reviews of studies for multiple clinical sites in batches.

Management System

To execute clinical trials smoothly, dedicated Site Management Associates staff with extensive experience and high-level skills responds to various needs as a comprehensive contact.

EP-SOGO reduces workload of clinical trial reviews for sponsors and clinical trial sites

セントラルIRBの概略図

Experience of Review

8 reviews per month. Maximum 4 new trials can be reviewed per meeting

EP-SOGO supports multiple Central IRBs. Major Central IRBs supported by EP-SOGO have 8 meetings per month, and maximum of 4 new trials can be reviewed per meeting. EP-SOGO has also supported Central IRB reviews entrusted by large scale hospitals such as university hospitals and national and public hospitals.

運営体制と受託実績

Dedicated Staff

Best Support by Highly Skilled Site Management Associates (SMAs)

About 30 dedicated SMAs support operation of central IRBs of partner medical institutions. Their average practical experience is more than 5 years and many of them have SMA qualification officially certified by the Japan Association of Site Management Organizations (JASMO). They can even handle irregular incidents (unpredictable situations related to a clinical trial) immediately and appropriately based on their rich practical experience. Also, EP-SOGO hosts in house training and case review meetings regularly to brush up on knowledge and skills continuously to maintain or improve the quality.

高いスキルを持った事務局員が的確にサポート

高いスキルを持った事務局員が的確にサポート

  • 全国展開
  • 専門性の高い集団

Supporting Operation of Certified Committee for Regenerative Medicine

PRP therapy, CGF regenerative therapy, and cancer immunotherapy can be reviewed

EP-SOGO supports Certified Committee for Regenerative Medicine certified by the Ministry of Health, Labour and Welfare as a committee to review plans to provide Class III regenerative medicine including immunotherapy, based on Act on the Safety of Regenerative Medicine enacted on November 25, 2014. Reviews of PRG therapy, CGF regenerative therapy, cancer immunotherapy, etc., can be entrusted to EP-SOGO. Also, feel free to consult with us about a procedure to start regenerative therapy. Please contact us using the contact form below.

リスクに応じた再生医療等性確保法の手続き

Contact

Please feel free to contact us for administrative support for central IRB, regenerative medical product review, etc.

Contact