Services

DOT ensures our high-quality clinical operations are ICH-GCP compliant for our clients. The strength of DOT is that we dynamically monitor our data collecting procedures and review our data management practices. We build specific quality systems for each trial and do the best to maintain accuracy and quality of our clinical outputs.

  • Confirming ICH-GCP and SOP compliance of monitoring operations
  • Managing the quality assurance check system
  • Verifying the completeness of ICH-GCP required documents
  • Managing the maintenance of ICH-GCP required archives
  • Hosting of regulatory authorized inspections
  • Developing and updating SOPs in compliance with ICH-GCP and other clinical laws
  • Executing SOP training

JCROA CDISC

DOT WORLD Co., Ltd. Comodio Shiodome 4F, 2-14-1 Higashi-Shimbashi, Minato-ku, Tokyo, 105-0021, Japan