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Clinical Safety Management

Kun Tuo’s clinical safety management team has expertise in regulations, SOPs and safety databases. We are also experienced in safety case processing and reporting. Working with our medical science affairs team, we are able to provide high-quality safety services to customers.

In addition to Kun Tuo’s SOPs, we comply with China GCP, ICH-GCP, relevant Chinese laws and regulations and project-specific requirements dictated by the sponsor or protocol.

Our clinical safety management services

  • Safety management in clinical trials (drug and Medical Device)
    • Develop safety management plan
    • Source information collection and data entry
    • Prepare case narrative
    • Query creation and management
    • Safety case follow-up
    • Prepare and submit safety report to regulatory authorities and sites
  • Collect spontaneous case reports for post-marketing products
    • Literature search of safety case 
    • Data entry and assessment 
    • Submission of safety report
  • 24-hour safety hotline service
  • In-sourcing of clinical safety management service

Clinical Safety Management