Safety Physicians

CONTINUUM offers the services of dedicated safety physicians to its clients. These physicians, while employed by CONTINUUM, are a part of the clients´ global product teams and support the following areas:

  • Benefit-risk evaluation, safety risk management and execution 

  • Signal detection

  • RMPs/REMS 

  • Responding to safety-related queries from internal and external sources

  • Responding to HA Assessment reports

  • Ad hoc reports 

  • Review of clinical protocols and study reports

  • Review of safety sections of IBs and regulatory authority submissions

  • Preparation, maintenance and review of DCSIs, CCSIs, USPIs and SmPCs

  • Presentations to Global Drug Safety and Labeling Committees and Health Authorities

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