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Shin Nippon Biomeidcal Laboratories, Ltd. Clinical Development Division
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We provide services at all stages of the drug development process. All projects from one-offs to complete development packages are undertaken in accordance with GCP regulations. The following is an outline of the services we provide.

  • Preparation of documents for investigational products
  • Preparation of clinical protocols
  • Preparation of explanatory documents for agreement acquisition
  • Selection of clinical trial sites
  • Selection of clinical trial personnel: controller, coordinator, medical expert, etc.
  • Contract support for medical institutions
  • Monitoring support
  • Delivery and collection of investigational products
  • Collection of case reports
  • Preparation of final reports
  • Preparation of theses for publication (clinical and non-clinical)
  • Manufacturing of pharmaceuticals and medical devises and preparation of import permit applications
  • Consultation with regulatory bodies and support and follow-up of regulatory submissions
  • Quality control
  • Quality assurance