Risk Minimisation Studies
OXON delivers studies measuring the effectiveness of routine and additional risk minimization measures (RMMs) to optimise the safe and effective use of a medicinal product in most therapy areas.
Planning and implementing risk minimisation measures and assessing their effectiveness are key elements of risk management. OXON has contributed to the ENCePP methods guide on this topic.
Many safety concerns may be adequately addressed by routine risk minimisation measures, but for some risks, however, additional risk minimisation measures are necessary to manage risk and/or improve the benefit-risk balance of a medicinal product.
OXON performs studies to measure the effectiveness of risk minimisation measures (RMMs) submitted by pharmaceutical companies to the European Medicines Agency as part of the post-authorisation regulatory requirements.
These studies aim to establish whether an intervention requested to minimise the risk of a medicinal product has been effective or not, and if not, why not and which corrective actions are necessary.
DESIGN, IMPLEMENTATION AND EVALUATION
OXON designs and implements measures and studies for the evaluation of risk minimisation tool in the effectiveness of products from diverse disease areas.
We provide a full service for risk management and risk minimisation: strategy planning, RMM design and implementation, PASS study design, questionnaire development, conduct analysis, reporting, regulatory submission support, and publication.