Clinical Trials Safety Services

Our safety team excels in offering a variety of clinical trials safety services.

Medical safety monitoring (Phase I-IV)

  • Assisting in assessing subject eligibility (e.g., incl. or excl. criteria)
  • Evaluating study protocols and informed consents
  • Assessing the benefits and risks on an ongoing basis
  • Good clinical practices (GCP) training

Safety monitoring and review

  • Analyzing and reporting SAEs/ESRs/SUSARs
  • Identifying safety signals and safety trends
  • Monitoring subjects’ safety throughout the trial
  • Assessing and ensuring regulatory compliance

Study documentations review

  • Annual safety report, annual IND report
  • IB development and update
  • Integrated summary of safety (ISS), summary of clinical safety (SCS),
  • Assisting in development of study protocol, informed consent form, case report form, SAE form, study reports

Other clinical development services

  • GCP Inspection support and training
  • Regulatory Clinical Trial Support and Strategic Consultation
  • Data Management
  • Quality Assurance