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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Blog: ICH GCP E6 (R3): transformative updates make good clinical practice better
The ICH GCP E6 (R3) updates represent a massive overhaul from the previous version. Learn topline impacts and next steps.
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Media article: Regulatory strategy implications for foetal medicine
In the February edition of TOPRA's Regulatory Rapporteur, ICON summarises the European legislation related to Regulation (EC) 1901/2006 and how it incorporates PIPs but omits the unborn foetus. We also review the guidelines and other application precedents while providing insight into distinctions that may be made by the agency in this matter, as well as highlighting relevant precedents which were identified during this peer reviewed article.
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Blog: Why translating core dossiers for marketing applications requires more than language skills
In this blog we outline why adoption of eCTD dossiers has increased and why translation requires regulatory expertise as well as language skills.
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Media article: Set for success. Avoiding the pitfalls of clinical data conformity in medical device trials
Regulatory Affairs article in Clinical Research News focusing on medical device regulatory challenges.
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Media article: Developing Robust Submission Strategies for Combined Studies
Though leadership article published in the January 2025 edition of the Journal for Clinical Studies
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Media article: Understanding EU regulatory requirements for studies with medical devices and in vitro diagnostic devices
2 page advertorial piece in the December 2024 edition of RAPS Quarterly In Focus Magazine
