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: Clinical trial protocol design amid evolving global IVD regulations
Clinical trial protocol design considerations driven by the current global evolution in vitro diagnostic device regulations impacting clinical testing laboratories
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Media article: ICON integrates Medidata’s Clinical Data Studio into clinical studies
The integration improves decision-making processes and supports AI-driven risk evaluation strategies.
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Blog: Navigating Pediatric Drug Development (PDP) in Canada: A comprehensive guide part 2
In the previous blog of this series, we introduced the pilot PDP initiated by Health Canada including the types of PDP that can be submitted and the content and format of a C-PDP. This blog discusses the review of PDPs by Health Canada, amending agreed-to PDPs and annual reporting requirements.
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Blog: Making sense of the regulatory web governing biosimilars development across APAC
In recent years the Asia-Pacific (APAC) region has represented an area of growth in the biopharmaceutical sector, with expanding drug production and development — including in the area of biosimilars.
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Blog: Reassessing the UK's regulatory landscape post-Brexit
Introduction to the post-Brexit regulatory environment in the UK, challenges, how they are being addressed and opportunities.
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Blog: Navigating Pediatric Drug Development (PDP) in Canada: A comprehensive guide part 1
Health Canada is taking steps to increase data availability to help health care providers by piloting a program for PDPs. In our series we review it & provide guidance.
