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Expertise in real world data
Safety
Risk management /minimisation
Full service provider of RMPs & observational PASS and risk minimisation studies
OXON has a wealth of experience in preparing EU RMPs.
Together with our global operational alliance CRO and global market research partner we provide a full service for risk management and minimisation: strategy, design, conduct and implementation, analysis, reporting and publications for PASS studies (including the evaluation of and and risk minimisation studies for including the evaluation of risk minimisation measures:
  • Observational studies
  • Patient registries
  • Drug utilisation studies
  • Surveys of physicians, patients and pharmacists
  • Indentification, design and validation of additional risk minimisation measures
  • Evaluation of additional risk minimisation measures
OXON provides a unique combination of expertise:
  • Clinical safety - Oxford trained, consultant-level (board-certified) physician who still sees hospital patients to guide and interpret analyses
  • Statistics - to appropriately design and run analyses
  • Pharmacovigilance - to ensure compliance with regulations and quality (former head of PV at Schering Plough)
  • Regulatory - a former senior member of the WHO monitoring centre acts as a consultant
  • ENCePP - our active participation in ENCePP at the EMA permits close relationship with EU regulators, which can help inform clients of the thinking of EU regulators
We have led and chaired many workshops on risk management in London
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