Ensuring patient safety

Ensuring patient safety lies at the heart of pharmacovigilance, driving confidence in every treatment, at every stage.

At ICON, we deliver end-to-end pharmacovigilance solutions designed to minimise risk and protect patient safety, from early clinical development through to post-marketing.

We combine advanced technologies with targeted data collection and multi-source reporting to detect, assess, understand, and mitigate adverse drug reactions. By evaluating safety data within the context of each product’s benefit-risk profile, we help ensure better outcomes for patients.

A technology-focused strategy to transform safety data

By embracing cutting-edge tools from the outset, we have achieved high-quality outcomes with significant efficiencies, reducing effort by approximately 50% compared to traditional methods.

Our Specialised Services team leverages a proactive, technology-enabled strategy to manage the rising volume and complexity of safety data. We integrate innovative tools and ensure alignment with evolving regulatory standards, to deliver timely, accurate insights that support informed decision-making and uphold the highest standards of patient safety.

The following advanced technology enables us to deliver exceptional flexibility and adaptability, meeting the unique needs of studies, projects, and sponsors while ensuring timely responses to queries.

Seamless safety data integration

We consolidate safety data from diverse sources, including regulatory authorities, electronic data capture (EDC) systems, safety databases, and real-world evidence (RWE), using advanced mapping templates that ensure smooth, standardised integration. This results in streamlined workflows and faster access to comprehensive safety profiles.

Intelligent insights from unstructured data

We use Natural Language Processing (NLP) to extract and classify meaningful insights, turning unstructured data into actionable knowledge for improved signal detection and context-aware decision-making.

Advanced data analytics & visualisation

We utilise cutting-edge business intelligence tools to deliver dynamic analysis and interactive visualisations at both macro and micro levels, enabling teams to uncover safety trends with precision and gain deeper insights for more informed risk assessments.

Technology-driven disproportionality analysis

We leverage automation to perform rapid and reliable disproportionality analyses, comparing observed events against expected baselines to uncover safety signals for faster identification of potential safety issues.

Expert safety surveillance & signal detection

ICON’s proactive approach to safety surveillance and signal detection enables the early identification of potential new safety concerns or shifts in known risks, while ensuring full compliance with the evolving regulatory landscape.

We provide clear, compliant communication of validated safety signals to regulatory authorities, healthcare professionals, and patients, ensuring transparency and trust at every level.

Safety management process

Our safety surveillance team monitors safety data to detect emerging signals and trends, while continually evaluating known risks and adverse events of special interest. Using our proprietary tool, Signet, we generate clear visualisations and outputs to support timely, data-driven decisions.

We also consult external sources such as regulatory and claims databases, and scientific literature when needed.

Signal assessment & validation

When signals require further evaluation, our experts assess:

prior awareness
strength of evidence

risk in sub-populations
clinical relevance

Prioritisation & risk evaluation

Signals are continuously prioritised based on their potential impact on a product’s benefit-risk profile, ensuring timely decisions and mitigation.

Depending on the outcome, we support the implementation of targeted actions, which may include:

Updates to core safety information, labeling (USPI, SmPC), or risk management plans
Development of follow-up tools and educational materials
Design and execution of Post-Authorisation Safety Studies (PASS)
Implementation of additional risk minimisation measures