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Expertise in real world data
- Why Oxon
- Consulting
- • Evidence strategy
To define and fill data gaps during the product cycle - • Decision analysis & modelling
Advanced statistical analysis of observational datasets & decision models for internal usein development - • Data Sources
Advice on medical data sources for studies - • Scientific committees
Participation bymembers of OXON
- • Evidence strategy
- Data integration
- HEOR
- Safety
- • Benefit-risk analysis for regulators
EMA methodsfor product approval & new PSUR - • Pharmacovigilance for observational studies
Compliance with EU legislation for observational studies - • Statistical signal detection analysis
Proactive use of company, FDA/WHO databases with senior clinical input - • Risk management / minimisation
Full service provider of RMPs & observational PASS and risk minimisation studies - • Solving Safety Concerns
Combination of PV, clinical and statistical expertise to proactively comply and respond to regulators
- • Benefit-risk analysis for regulators
- Epidemiology
- • Field studies
Full service provider of single & multi-country observational & PASS studies - • Database studies
Retrospective and hybrid studies of medical record data - • Patient registries
National & multi-country disease & product registries - • Retrospective chart review studies
Single & multi-country retrospective & validation studies
- • Field studies