Sponsors face growing pressure to manage complex clinical data while meeting tight timelines and ensuring quality and patient safety. Disconnected systems, inconsistent data, and manual processes delay insights, leading to slower decisions, higher costs, and increased risk.
At ICON, we deliver tailored clinical data science solutions that go beyond traditional data management. Using advanced analytics and risk-based strategies, we generate high-quality data to support faster decisions and enhance patient safety. Trusted for our agility, innovation, and industry-leading expertise, we leverage our global scale to create cost-effective solutions that drive success at every stage of your study.
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3,700+
Global professionals -
2,000+
EDC studies completed -
75%
Up to 75% reduction in resource costs -
1-400+
Long term FSP partnership
With over 3,700 experts worldwide, ICON provides flexible, on-demand support through onshore, nearshore, and offshore models. Backed by 20 years of experience, we co-design tailored solutions to meet sponsor needs.
Our governance models and KPIs integrate seamlessly with sponsor teams, offering transparency and aligned insights. Proven processes enable the successful setup and growth of client-dedicated resourcing hubs, improving efficiency and performance.
Scalable and fully customisable models
ICON is a trusted partner to pharmaceutical, biotech, and medical device organisations of all sizes. We support sponsors in building and optimising high-performing functional teams, with tailored oversight of clinical data science activities to ensure seamless execution. Through strong leadership and a focus on consistent delivery, we help sponsors 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.
Operational Product Management
Our team provides strategic system support across the Clinical Data Science lifecycle, from implementation to optimisation. We assess business impact, manage changes and upgrades, and maintain strong vendor relationships to ensure effective communication, issue resolution, and continuous improvement.
Standards Consulting
Our CDISC experts provide end-to-end standards consulting, from customised training and study data reviews to supporting standards development, implementation, and governance. We also offer guidance on SDTM mapping, ADaM principles, FDA data requirements, and standardisation planning.
Data visualisation and decision support
Our visualisation tools accelerate data review, enabling continuous quality assessment and process improvement across trials. Key capabilities include flexible, interoperable architecture, unified platforms for clinical data and safety monitoring, and ICON’s Clinical Data Repository, which automates data ingestion and standardisation as part of our “collect, curate, consume” model.
Leading technology and innovation
ICON is committed to cutting-edge technology, leading data review, and AI-driven innovations. Our innovation council encourages the sharing and implementation of new ideas. We offer out-of-the-box provisioning for key review tools, including interactive visualisations like the Clean Patient Tracker and Audit Trail Review platforms.
We deliver rapid electronic data capture (EDC) builds using sponsor or ICON platforms, with expertise across Medidata Rave, Veeva CDMS, Oracle InForm, ClinInfo, and more.
Our validated clinical systems ensure:
- Strict standards control and deployment
- Efficient review and approval workflows
- Interactive online meetings and user acceptance testing
- Complete clinical database builds with modular features
- Seamless, out-of-the-box system integrations
Clinical Data Studio
As a comprehensive solution, ICON has implemented Clinical Data Studio to unify data from multiple sources, automate processes, and provide real-time, actionable insights. This platform accelerates clinical discovery and supports diverse functions including clinical data science, central monitoring, clinical operations, medical monitoring, and clinical programming. Clinical Data Studio empowers teams with greater agility, improved data quality, and enhanced decision-making by automating repetitive tasks and integrating disparate data sources.
Navigating the regulatory landscape in the US and Japan
A guide to global submission standards for clinical data
This whitepaper provides practical guidance to help sponsors navigate evolving FDA and PMDA submission requirements for clinical data, highlighting both differences and opportunities for harmonisation.
Clinical data science blogs and media contributions
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Media article: Harmonising outsourcing to keep clinical trials on track
Debbie Gilmore, Vice President, outlines how strategic partnerships and approaches to outsourcing can be used to navigate a complex clinical research landscape.
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Media article: Confidently compliant? Considerations for industry players to meet the new EMA guideline
Vesta Marciulioniene, Director, Global Regulatory Clinical Services and Jo Hulbert, Executive Director, Global Regulatory Clinical Services provide an overview of the EMA’s new framework on computerised systems and electronic data in clinical trials in this article from XTalks Clinical Edge.
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Blog: Keeping up to date with the latest regulatory developments for decentralised clinical trials
This blog examines the crucial topic of regulating the use of DCTs, exploring what’s in place now and what sponsors need to consider as these methods continue to gain traction.
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Media article: Modern partnerships with CROs
In this article in Contract Pharma, ICON SMEs share insight on strategic and blended outsourcing models and trends in today’s market.
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Media article: Considerations for safety data migration methods
This article explains how to handle the different types of data migration methods and how companies can select the optimum approach to ensure data integrity is maintained.
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Blog: The new EMA guideline expectations
In this blog, discover more about the new EMA guideline on computerised systems and electronic data in clinical trials.
