CALLE DOCTOR FLEMING, 51 | 28036 MADRID, SPAIN
+34 91 3459395
info@oxonepi.com

Pharmacovigilance and Drug Safety

Pharmacovigilance and Drug Safety

We help audit drug safety procedures and provide appropriate risk management plans to manage your product safety programme

OXON provides global safety and pharmacovigilance consulting services to enhance patient care and patient safety in relation to the use of medicines and acquiring reliable information for the effective assessment of the risk-benefit profile of medicines. 

Full safety

OXON offers full safety services or standalone solutions in global drug safety and pharmacovigilance studies.

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 programme to comply with regulations and guidance.

We offer pharmaceutical companies:

• Local contact for PV, as required by local regulations
• 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
• Conducting post-authorization safety and efficacy studies
• Evaluation of existing pharmacovigilance activities (SOPs, literature research, reporting, etc.) and measures to minimise risk.

RISK MANAGEMENT

We have experience in helping small and medium-sized companies with the compilation of the safety part of the Common Technical Document in preparation for drug approval.

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

We provide 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.

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