Pharmacovigilance and Drug Safety
OXON provides global safety and pharmacovigilance services to ensure all our observational studies are compliant with local regulations.
Our CRO services includes audit drug safety procedures and appropriate risk management plans to manage your product safety programme
Safety surveillance
OXON manages adverse events within observational studies to support clients.
We offer full services or standalone solutions in global drug safety and pharmacovigilance studies to enhance patient safety and deliver reliable information for the effective assessment of the risk-benefit of medicines.
PHARMACOVIGILANCE
Our pharmacovigilance team, headed by an expert with over 20 years of industry experience, have the knowledge of local and EU regulations and standards needed to identify and assess risks and conduct a comprehensive drug safety and pharmacovigilance plan for your observational studies to comply with regulations and guidance.
We offer pharmaceutical companies:
– Observational studies: ensuring compliance with regulations and quality, in all the PV aspects of the studies
– Definition of procedures to obtain accurate and verifiable information for the evaluation of adverse reaction reports
– Local contact for PV, as required by local regulations for studies
– Conducting post-authorization safety and efficacy studies
– Evaluation of existing pharmacovigilance activities and measures to minimise risk.
RISK MANAGEMENT
OXON has experience in helping small and medium-sized companies with the compilation of the risk management plan.
We provide consulting to guide strategy for post-marketing safety studies and risk minimization studies. Furthermore, we can help in your discussions with regulatory authorities. OXON has successfully helped companies to:
– Reject infeasible studies requested by EMA
– Remove ineffective additional risk minimization measures imposed by EMA
We rely on:
Pharmacovigilance expertise to ensure compliance with regulations and quality (former head of PV at Schering Plough)
Statistical expertise from a reputed academic professor of medical statistics in London, with many years of experience of sitting on data monitoring committees for pre-and post-approval trials. He has served on the UK MHRA advisory committee and UK Commission for Human Medicines, and acts as a consultant to OXON
Clinical expertise in safety from an Oxford trained, consultant-level (board-certified) physician who still sees hospital patients to guide and interpret analyses.
OXON provides a full service for risk management and minimisation: strategy, design, conducting, implementation, analysis, reporting and publications for PASS studies. Our service can be applied to:
• Observational studies
• Patient registries
• Drug utilisation studies
• Surveys of physicians, patients, and pharmacists
• Identification, design, and validation of additional risk minimisation measures
• Evaluation of additional risk minimisation measures.
BENEFIT-RISK ANALYSIS
Our CRO provides a comprehensive service not widely available among CROs or consultancies for conducting quantitative benefit risk analysis between products.
Expertise in quantitative benefit-risk analysis: we have published benefit-risk analysis using multi-criteria decision analysis (EMA preferred method). We utilise sales, WHO and FDA spontaneous events data and disproportionality analysis methods 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.