ICON’s safety surveillance services employ a robust signal detection and management framework to identify potential risks posed by medicinal products. A dedicated global team utilise the latest validated technology combined with tested procedures to ensure continuous monitoring of these products from clinical trials to the post-market phase.
A medicinal product must undergo safety surveillance through a strictly controlled clinical development process (which can continue after the product is licensed), to qualify for patient use. The net benefit of a potential medicinal product is dependent on mitigating any associated safety risks. Good Pharmacovigilance Practice provides an industry based, structured methodology for signal detection for the identification of risks for a medicinal product.
Pharmacovigilance regulations are implemented to ensure identification and monitoring of safety concerns, analysis of data and risk assessment in a continuous and systematic manner. The change in the European Union Clinical Trial Regulation has also impacted safety reporting measures in EEA member states, further strengthening safety protocol and surveillance for medicinal products. ICON’s processes follow these strict regulations in developing their safety surveillance plan based on the five-fold system of detection, validation, assessment, recommended action and communication of findings while ensuring signal prioritisation and tracking.
Signal detection pertains to the identification of potential safety issues associated with a medicinal product using qualitative and/or quantitative analysis of safety data from different sources. The validation process analyses the strength of available evidence, their clinical relevance and previous awareness of the association, which is followed by further assessment, signal to risk translation and benefit risk evaluation. Actions are recommended in the event of confirmation of a safety issue. Finally, the findings are communicated to the stakeholders.
The detection process can be divided into the following phases:
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Generating Signal Detection Strategy
The strategy for detecting signals is based on the product safety profile, the available data sources, signal detection method and data output format. It also requires the involvement of a Safety Surveillance Team (SST) and implementation of a governance structure. Every product passes through this signal detection cycle, and the strategy helps in identifying the relevant clinical and safety data to be reviewed by the SST. Additionally, details associated with each phase in the safety surveillance process are available for reference.
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Conducting Signal Detection Review
ICON uses SIGNET, a data visualisation tool, for safety surveillance and signal detection. It uses near real-time data, is cost-effective and time efficient. Raw clinical, safety and public data are ingested into the tool and the resulting visualisations help in identifying trends and areas of interest by allowing ‘slicing’ and ‘dicing’ of data.
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Managing Signal Detection Findings
Based on signal detection findings a report is prepared. Validation and assessment of signals take place after signal detection findings are reported. The SST, which includes client representation, confirms signal validation and assessment criteria and conclusions, and proposes actions to manage and minimise safety risks associated with the product. ICON also uses Orbit™ to track the flow of activities related to detected signals and that of further actions resulting from signal assessment.
Overall, ICON processes for safety surveillance involve an extensive plan of managing the safety profile of medicinal products in accordance with country specific safety regulations for Sponsors and Market Authorisation Holders for a well-controlled product life-cycle that ensures drugs are safe for use.
In this section
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Digital Disruption
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
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Personalising Digital Health
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The triad of trust: Navigating real-world healthcare data integration
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
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Glycomics
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Oncology
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Advanced therapies for rare diseases
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Accelerating biotech innovation from discovery to commercialisation
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Global Outcomes Benchmarking
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Perspectives from US payers
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Making Sense of the Biosimilars Market
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payers Perspectives on Digital Therapeutics
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