PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY

Accurate and comprehensive pharmacovigilance systems and pharmacoepidemiology activities throughout the entire product life cycle are essential to protect patients and public health. Symyoo’s pharmacovigilance and pharmacoepidemiology (PV&PE) team has spent multiple years working in the pharmaceutical company and has first-hand knowledge of regulatory requirements and therapeutic experience. Symyoo’s PV & PE team offers high-quality services to support thorough examination and quality control of all safety reports as well as comprehensive assessment of risk-benefit of drug use and is dedicated to ensure that projects comply with changing regulatory environments.

    Services

  • Consulting
  • Study Design, Operation, and Management
  • Non-Interventional / Observational Study
    Registry Study
    Post-Authorization Safety Study
    Epidemiologic Study etc.
  • Regulatory and IRB Affairs for Pharmacoepidemiology Studies
  • Management and Reporting of (Serious) Adverse Events
  • Periodic/Final Report Writing
  • Post-Marketing Surveillance (PMS)