Benefit-risk analysis for regulators
We provide a comprehensive service not widely available among CROs or consultancies for conducting quantitative benefit risk analysis between products.
Quantitative benefit-risk assessment requires all of the following ingredients:
Expertise in epidemiology and trials and meta-analysis
Are all required: we have worked in big pharma (SB, GSK, Pfizer, Pharmacia, AZ), published in the top medical major journals ((x7) Lancet, (x1) JAMA and (x3) BMJ), led a Cochrane group, have an honorary senior lecturer in epidemiology at the London School of Hygiene and Tropical Medicine, London University, and are currently leading an initiative at the EMA on data integration for safety which is highly relevant to benefit-risk analysis.
Expertise in quantitative benefit-risk analysis:
We have published benefit-risk analysis using multi-criteria decision analysis (EMA preferred method). We utilise sales, and company, WHO and FDA spontaneous events data and disproportionality analyses to input into models. We use EU electronic health record databases (e.g. GPRD, THIN etc.) to populate models with real world data where necessary, and have access to academic statisticians in Cambridge and London (a world renowned professor of medical statistics) as consultants.
Clinical (and patient-reported outcomes) expertise:
To sensibly interpret and guide these elements, we have an honorary consultant geriatrician and a patient-reported outcomes researcher, rapid access to practising hospital clinical consultants in a range of therapeutic areas and an Oxford professor of patient reported outcomes as a consultant.
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