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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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What we do
Prospective observational studies and registries, retrospective chart review cohort and cross-sectional studies, cross-sectional surveys, database studies, hybrid field and database studies, risk minimisation , Risk management plans, pragmatic trials, data aggregation and integration, Meta-analysis, H-E / Q.O.L. within observational studies, Consulting, , Validated eDC and e-Technologies,.
Contact
Oxon Epidemiology S.L.
The Euston Office
1 Euston Square
40 Melton Street
London NW1 2FD
Tlf: +44(0) 203 574 4965
Fax: +44(0) 203 397 7497
E-mail:
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