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Ensuring patient safety

From clinical development to post-marketing

We provide a comprehensive range of drug safety services, minimising risk and protecting patient well-being from clinical development to post-marketing.

By using versatile technologies, targeted data collection, and reports from multiple sources, our experts support our clients in protecting patients. These services help to detect, assess, understand, quantify, and minimise the risk of adverse reactions. We use the context of the product’s benefit-risk profile to ensure patient safety.

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Safety surveillance & signal detection

Our approach to safety surveillance and signal detection enables us to identify potential safety concerns early and ensure compliance with today’s ever-changing regulatory environment.

Safety management process:

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Our safety surveillance team performs analysis of signals or trends that may be evident in a dataset as well as monitoring and review of any adverse events of special interest. ICON can generate meaningful outputs and visualisations using Spotfire® to facilitate the review of safety data and identification of safety signals.

Where signal validation and assessment are required, we can support review of prior awareness, strength of the evidence, analysis of sub-population at higher risk and clinical relevance of the signal. If need be, ICON assesses other relevant data sources such as regulatory databases, claims databases or scientific literature.

Prioritisation is assessed throughout the whole process by evaluating the impact on the benefit-risk balance of the product ensuring the timely disposition of safety concerns.

Proposed actions are tailored to each safety signal taking into account the benefit-risk balance of the medicinal product and the impact on patient safety. Actions may include update to the Company Core Safety Information, update to USPI, SmPC and other local labeling, update to the risk management plan, generation of targeted follow-up questionnaires, design and execution of Post-Authorisation Safety Studies, development of educational materials and other risk minimisation measures. The PVS team can support our clients with communication of the safety signal to the health authorities but also to health care professionals and patients.

 

Aggregate safety reports

Our Safety Teams have extensive experience in the generation of aggregate safety reports, such as DSURs, IND Annual Reports, PBRERs, and PADERs. They understand the expectations of health authorities. Each report summarises relevant safety information, assesses the information scientifically, and evaluates benefits and risks in an integrated approach.

We track all steps of aggregate safety reports through planning, generation, and reporting via our Orbit system for compliance with regulatory requirements, full transparency and inspection readiness.

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Risk management

ICON recognises that risk management in support of a medicinal product (drug, biologic, vaccine) is applicable at any stage of development and is often a significant component of the product’s life cycle.

Our risk management team is an integrated global team with substantial experience identifying innovative solutions to satisfy regulatory requirements and providing fit-for-purpose strategies to meet client needs for risk management. Our approach begins at proof-of-concept and early development and continues throughout the lifecycle of the medicinal product. We design a product-specific risk management system characterising and minimise risks to patient safety. Using lessons learned and strategies acquired through decades of experience, our team of risk management experts collaborate with clients to identify the critical regulatory requirements for successful risk management planning and execution.

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