Risk Benefit Optimization

We provide expert scientific counselling, guidance, and medical consultancy. Obtain assistance prior to European Medicines Agency (EMA) and Food and Drug Administration (FDA) reviews, and around the communication of product safety and environmental risk issues. Our specialized research and consultancy help manage and prevent known or potential risks associated with a specific treatment.

We can help you with all steps of designing and executing a post-authorization safety study (PASS) or post-authorization efficacy study (PAES). Our solutions enable you to adhere to risk management requirements, establish evidence for safety and effectiveness, assess health outcomes and economic benefits, and investigate the frequency of a medicine’s known adverse events and potential risks in a population of real-life users. 

Robust and scientific design using patient records for evaluating a drug's usage under real-world conditions. This includes treatment and prescription patterns, drug monitoring by the prescribing  physician, and level of physician and patient knowledge about the drug.

Evaluate the probability and frequency of adverse events as part of post-marketing risk assessment for medical products, interacting directly with patients using a specific treatment.

Assess a drug's safety profile in the exposed population. Our expert team will provide consultancy and support for setting a new registry or using existing registries to fulfill your safety needs.                             

Through electronic health records (EHR), claims, and existing registries, we can help you identify existing data that can providence a drug's safety information. Work with an expert, dedicated team highly specialized in safety and claims data analytics for scientific, strategic, and regulatory consultancy, to choose the most-appropriate source for early safety signal detection.