Risk Benefit Optimization

Increasing regulatory pressure makes it vital to demonstrate drug safety, effectiveness, and post-approval utilization patterns under real-world conditions. We support your medical risk evaluation and management to help you optimize benefits and detect risks early on.

Risk benefit optimization with Oracle

Risk evaluation and mitigation strategy and risk management plans

The European Medicines Agency (EMA) and Food and Drug Administration (FDA) require a Risk Evaluation and Mitigation Strategy (REMS) and Risk Management Plan (RMP) to ensure that the drug's benefits outweigh patient risks, and that risks are minimized as much as possible.

We provide expert scientific counselling, guidance, and medical consultation. Get support for EMA and FDA reviews and clearly communicate product safety and environmental risk issues. Our specialized consultants can help you manage and prevent known or potential risks associated with a specific treatment.

Design of post-authorization safety and efficacy studies

We help design and execute post-authorization safety studies (PASS) and post-authorization efficacy studies (PAES). Partner with us to adhere to risk management requirements and establish evidence for therapeutic safety and effectiveness. We assess health outcomes and economic benefits, investigate the frequency of a medicine’s known adverse events, and clarify the potential risks involved with a population of real-life users.

Evaluation through drug utilization studies (DUS)

We evaluate a drug’s usage under real-world conditions with robust and scientific study designs that utilize patient records. We identify treatment and prescription patterns and assess the level of physician and patient knowledge of a drug.

Utilization of active drug surveillance studies

We interact directly with patients receiving a specific treatment, supporting your evaluation of the probability and frequency of adverse events as part of the post-marketing risk assessment for medical products.

Product registries to fulfill your safety needs

Our expert team provides consultancy and support for setting up new registries. Alternatively, we can use existing registries to fulfill your safety needs, enabling you to assess a drug's safety profile within the exposed population.

Utilization of secondary data research to devise safety information

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

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