Pharmacovigilance
Enhancing the safety profile of your product across all lifecycle phases
-
1200+
Pharmacovigilance staff -
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 1,200 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.
- Safety Reporting Solution
- PV Affiliate Solution
- Cost effective high-quality case processing model
- Assigned functional lead for clear communication routes and accountability
- Industry-leading pharmacovigilance regulatory intelligence for over 100 countries
- Global reach and round-the-clock coverage for Clinical Trials, Post-Marketing and Medical Device submissions
- Pharmacovigilance specialised services including safety surveillance, aggregate safety report generation, risk management solutions, literature surveillance
- Global Medical Information Call Centre services
- Over 99% compliance with regulatory reporting timelines
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 are equipped to help you monitor and define the safety profile of your investigational and/or marketed products. Our safety surveillance processes support the detection, management, and minimisation of safety concerns and important safety risks to ensure patient safety.
Resourcing models
We offer a range of safety resourcing models that can be tailored into a customised solution to meet the specific needs of your study:
- Unit based model
- Full-time equivalent (FTE) based model
- Embedded SolutionsTM staffing model
- Workforce transfer – transfer safety staff from existing PV team to ICON
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. Since 2021, we have successfully processed over 700,000 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.
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