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Expertise in real world data
Safety
Statistical signal detection analysis
Proactive use of company, FDA/WHO databases with senior clinical input
Proactive use of company, FDA/WHO databases and senior clinical input
We provide statistical signal detection, monitoring and evaluation of spontaneous adverse events using company, FDA (AERS) and WHO (Vigibase) databases to small & medium sized clients
Analyses can be provided as regular reports or ad-hoc reports for special requests or as part of the response to regulatory requests.
OXON provides a unique combination of expertise in:
  • 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
We have run training workshops on signal detection in London for several years
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