Pharmacovigilance

Pharmacovigilance

CR Medicon team provides advanced pharmacovigilance solutions. We provide IND-filing needed information on the establishment of Pharmacovigilance System, Safety Management Plan, the Individual Case Safety Report (ICSR), and Drug Safety Update Reports  (DSUR). We use Oracle Argus system and BioKnow Security Alert Management System with our services.

Services

  • Early detection of unknown adverse reactions and interactions
  • Identify risk factors
  • Discover the trend of known adverse reactions and monitor the dynamics of adverse drug reactions
  • Analyze risk factors and possible mechanisms of adverse drug reactions
  • Conduct quantitative analysis of risk/benefit evaluation, release of relevant information, promotion of drug supervision and management, and guidance of clinical medication

Advantages

  • Complete adverse reaction statistics from many hospitals
  • Help clients comply with clinical trial safety data reports
  • Assist clients in drug registration
  • Meet client’s regulatory compliance and patient safety requirements
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