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1,000+
Global pharmacovigilance professionals -
100+
Countries -
99%
Compliance with regulatory reporting timelines
Seamless and transparent pharmacovigilance solutions
A comprehensive approach to collecting and assessing product safety information is critical for the success of clinical research and the maintenance of post-marketing product licenses. Our team of over 1,000 global pharmacovigilance professionals integrates all safety services into a streamlined, transparent delivery model, providing clear, easy-to-review outputs with a strong commitment to continuous quality improvement and operational efficiency.
- Assigned functional lead for clear communication routes and accountability
- Industry-leading pharmacovigilance regulatory intelligence for over 100 countries
- Over 99% compliance with regulatory reporting timelines
- Global reach and round-the-clock coverage for Clinical Trials, Post-Marketing and Medical Device submissions
- Cost effective high-quality case processing model
- ICON ORCA Safety
- PV Affiliate Solution
- Global Medical Information Call Centre services
- Pharmacovigilance specialised services including safety surveillance, aggregate safety report generation, risk management solutions, literature surveillance
Tailored pharmacovigilance solutions for biotech and small to mid-sized companies
At ICON, we recognise that biotech and small to mid-sized companies have distinct needs that set them apart from larger pharmaceutical firms. Our flexible, scalable, and cost-effective pharmacovigilance solutions are specifically designed to address these unique requirements. We ensure that you receive the same high level of personalised service, regardless of your organisation's size. Our pharmacovigilance solutions can be customised to meet your needs and evolve alongside your business.
Safety Reporting Group
ICON’s Safety Reporting Group ensures seamless regulatory compliance and efficient safety management, supported by advanced automation and global expertise.
Risk Management and Risk Evaluation & Mitigation Strategy (REMS) Solutions
Our integrated Risk Management team forms a comprehensive risk management solution tailored to the specific nature and needs of each of our clients. Our experts provide unparalleled support in managing risks throughout a product’s lifecycle.
Ensuring patient safety
From clinical development to post-marketing
Our safety experts use advanced technologies to monitor and define the safety profile of investigational and marketed products, supporting the early detection and management of safety risks to ensure patient safety.
Safety writing solutions
Our team of safety medical writers and scientists delivers compliant, cost-effective safety writing solutions, including aggregate reports, risk management planning, and document reviews, ensuring global regulatory compliance.
Scalable and fully customisable models
ICON is a trusted, market-leading partner to pharmaceutical, biotech and medical device organisations of all sizes. We are dedicated to helping sponsors implement, manage, and optimise high-performing functional teams.
Our leadership approach provides bespoke oversight of pharmacovigilance activities, ensuring our clients’ projects run seamlessly. By driving team performance and guaranteeing consistent, successful delivery, we empower sponsors to achieve their trial goals with confidence and precision.
We offer a wide range of customisable operating models to meet your needs, whether using ICON systems, sponsor systems, or a hybrid approach. Services can be delivered as consulting, standalone, FSP, blended or full service and across all therapeutic areas.
Robust project documentation and management
Successful project delivery relies on comprehensive project documentation, managed by skilled project personnel. At ICON, we maintain an extensive library of SOPs and procedures governing our pharmacovigilance services to ensure thorough staff training and high-quality standards.
Each client is assigned a functional lead who oversees all activities and ensures that deliverables consistently meet defined Key Performance Indicators (KPIs).
Global and local literature monitoring
With over 15 years of experience in specialised literature search services, ICON offers robust expertise in conducting searches through platforms like PubMed and Embase. We provide both routine weekly monitoring and comprehensive reviews for periodic report generation and signal management.
Our expert literature team also conducts local literature surveillance in compliance with regional regulations and meticulously reviews results from the European Medicines Agency’s medical literature monitoring (MLM) program.
Case processing
ICON delivers tailored solutions to support our clients at every stage of the product lifecycle, from early development through to commercialisation.
Our comprehensive case processing capabilities include receipt, data entry, narrative writing, coding, quality control, medical review, query management, and safety submissions. We process hundreds of thousands of cases, demonstrating our commitment to high-quality, efficient safety management.
ARGUS safety database
Using the Oracle ARGUS safety database, we configure a dedicated schema tailored to each client’s needs. The system is fully compliant with FDA 21 CFR Part 11 regulations and supports the generation of all standard regulatory and periodic reports.
In addition, we offer extensive expertise in database migrations, having successfully taken over ongoing studies from other CROs and seamlessly transferred legacy databases containing over 5,000 cases.
Pharmacovigilance blogs and media contributions
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Blog: The impact of COVID-19 on pharmacovigilance
COVID-19 is affecting how clinical trials are managed, in terms of patient recruitment, patient care, data collection, analysis and safety reporting.
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Media article: The Significant Role of a Robust Regulatory Intelligence Process in Global Safety Submissions
Pharmacovigilance insights on the efforts towards the international standardisation of electronic transmission of drug safety information to achieve a unified objective of patient safety.
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Media article: Navigating an Ever Evolving Regulatory and Pharmacovigilance Landscape
In the 2020 edition of SCRIP Asia 100 ICON's Chuhua Wu outlines the variations in the structures, processes and outcomes of the pharmacovigilance status among Asian countries, with many diversities and complexities, and how a trend toward a more stringent regulatory environment in Asia is predicted.
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Blog: Limiting Potential Carcinogenic Risk in Drug Development with Reliable Predictions
ICON's Mgr, Nonclinical Safety Assessment, Drug Development Consulting discusses the challenges & opportunities of in silico analysis in toxicology.
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Blog: EMA ISO IDMP - The path forward
The EMA is implementing the standards developed by the ISO for the IDMP.
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Blog: The final countdown to the overhaul of Pharmacovigilance in the EEA
In October, the European Medicines Agency (EMA) released their much anticipated Go-Live plan following input from all of the National Competent Authorities in the European Economic Area (EEA).
