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Expertise in real world data
Safety
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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