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Expertise in real world data
Solving Safety Concerns
Combination of PV, clinical and statistical expertise to proactively comply and respond to regulators
OXON have experience of helping small and medium-sized companies in the compilation of the safety part of the CTD in preparation for drug approval. We work with clients (and guide the CRO conducting the statistical analysis) on:
  • Integrated safety summary
  • Discussion documents for selected safety topics
  • Clinical input to safety issues
  • Statistical evaluation
  • Epidemiological input
We have recourse to:
Statistical expertise - a world renowned academic professor of medical statistics in London, with many years of experience of sitting on data monitoring committees for pre-and post-approval trials, and has served on the UK MHRA advisory committee and UK Commission for Human Medicines, acts as a consultant to OXON
Clinical expertise in safety - An Oxford trained, consultant-level (board-certified) physician who still sees hospital patients to guide and interpret analyses
Pharmacovigilance expertise - to ensure compliance with regulations and quality (former head of PV at Schering Plough)
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