SMO services

  • Core Activities
    Core services are the supporting of CT activities for improving the quality and the speed of CT.
  • Customers
    Supporting both investigational hospitals (sites) as a Site Management Organization (SMO) and pharmaceutical companies (sponsors) as a Contract Research Organization (CRO).
  • Compliance
    Providing the Japanese quality services to the sites and/or sponsors complying with ICH-GCP and V-GCP based on the contract

Core SMO Services

  • Supporting creation of site SOPs (Standard operating Procedures) and Preparation of compliant document forms  needed for CT process
  • Training and dispatch of CRCs (Clinical Research Coordinators)
    • Training and dispatching CRCs to sites
    • Managing CRC activities’ quality
  • Support for principal investigator and other CT staff in complying with GCP, protocol and SOPs, ect.

Support for principal investigator and other CT staff in CT Administrative operations

Support Investigator to comply with GCP, protocol, SOPs and other applicable regulatory requirements through CT Administrative operations 

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