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Shin Nippon Biomeidcal Laboratories, Ltd. Clinical Development Division
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We design case report forms in parallel with the development of the trial protocol, from which we establish procedures for data collection. In the performance of clinical trials we register trial subjects, control the eligibility of subjects, assign subjects to trials, manage blanking and provide trial progress management. In addition, as monitoring support, we ensure the quality of case reports and data input procedures. Our data input is compatible with all types of clinical trial database. We provide the following services:

  • Data Management Planning
  • Preparation of sample case reports
  • Definition of clinical trial data
  • Input of clinical trial data
  • Data screening for case reports
  • Records of changes and revision of case reports (inspection prints)
  • Data bases of clinical trial data corresponding to ICH
  • Quality assurance of data processing (input, changes, revisions and output)
  • Storage of clinical trial data