Introducing clinical intelligence:
Human expertise. Connected data. AI acceleration.
Our technology partners and solutions.
One partnership to deliver better outcomes with ICON’s clinical intelligence ecosystem.
Clinical intelligence. Three pillars. One ecosystem.
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human expertise
One partnership, bringing 30+ years of expertise at every decision point. -
connected data
We bring diverse data sources together in a structured, interoperable way, underpinned by a robust data foundation to ensure insights can be applied consistently and responsibly. -
aI acceleration
AI ecosystem, powered by Orbis, supporting clinical trial delivery from early design through closeout.
Clinical intelligence vision paper
Discover how clinical intelligence is transforming the way development teams generate insights, manage complexity, and accelerate decision-making across the clinical lifecycle.
Trial initiation
ICON is using and expanding AI supported protocol digitisation and optimisation capabilities to convert protocols into structured data and surface potential operational risks earlier. These approaches help teams identify inconsistencies, reduce patient and site burden, and make more informed design decisions up front, with the aim of reducing amendments and rework downstream.
Trial setup
ICON is using and further developing AI enabled solutions to support feasibility assessment, contracting, and informed consent workflows. This includes the use of precedent based intelligence to assist with contract drafting, as well as automated support for consent documentation updates. These capabilities are designed to reduce manual effort, improve consistency, and support more predictable study activation.
Trial execution
ICON is deploying and expanding AI supported monitoring environments that bring data from multiple systems into more unified workspaces for CRAs and operational teams. These platforms provide contextual protocol guidance, highlight emerging site risks, and support prioritisation of activities. Increasingly, this is enabled by agentic AI — systems that can assist with coordinating defined tasks and workflows, while remaining under expert human oversight.
Trial close‑out
ICON is applying automation and AI assistance to areas such as data processing, analysis outputs, and draft report generation. These capabilities, which continue to evolve, are focused on shortening timelines from database lock to submission while preserving data quality, traceability, and regulatory compliance.
Orbis agentic AI
Orbis is ICON’s multi-agent agentic AI framework and agent services platform, powering a connected ecosystem of AI agents across teams, processes and technology.
Governance and trust as standard
Our AI ethics committee, compliance rigor, and data privacy framework are not add-ons. They are the foundation. In a regulated industry, the confidence to act on AI-generated insights depends entirely on whether those insights can be trusted, traced, and defended. ICON's governance infrastructure gives you that assurance.
One Search
ICON’s AI-powered site selection tool that analyses extensive data to find the best sites quickly; reduces time to identify sites by ~53% and cuts non-enrolling sites by up to 50%.
ICONex
Visualises expert networks and key opinion leaders, particularly for rare diseases, speeding up protocol design and feasibility planning.
Cassandra
Uses AI and ML on real-world post-marketing requirements data from FDA and EMA to predict postmarketing requirements as early as Phase I with ~99% accuracy.
iSubmit
AI-driven automation for eTMF filing and document management, reducing administrative burden, improving indexing, and cutting audit findings.
MRT COA
An AI-powered outcomes intelligence tool that auto-updates the eCOA database in near real-time using NLP and fine-tuned large language models, supporting outcomes strategy.
SmartDraft
SmartDraft is our AI-powered solution that transforms one of the most time-consuming and manual aspects of study start-up. By learning from thousands of historical contracts, IT streamlines precedent selection, accelerates negotiations, and reduces the friction in global site contracting.
EngageAI
EngageAI transforms collated customer feedback into structured reports at unprecedented speed and scale. It summarises feedback, analyses sentiment, and identifies key themes.
AI blogs and media articles
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Media article: ICON partners with Anthropic in multi-year collaboration to deploy Claude's frontier AI across the clinical trial lifecycle
ICON's multi-year collaboration with Anthropic will bring Claude's AI capabilities to key clinical development workflows, helping accelerate innovation and enhance the delivery of clinical trials worldwide.
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Media article: ICON to deploy Claude AI across clinical trial lifecycle
ICON is deploying Claude AI across its organisation and clinical development operations, combining advanced AI capabilities with deep clinical expertise to improve efficiency, productivity and decision-making.
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Media article: ICON partners with Anthropic to integrate Claude AI in clinical trials
ICON has partnered with Anthropic to integrate Claude's frontier AI capabilities into the clinical trial lifecycle through its secure Orbis platform, advancing study planning, trial intelligence and protocol optimisation.
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Media article: June 2026 Medical/ Commercial Pulse Check
With the first EU JCAs finalized and CMS extending deadlines for its ambitious Medicaid international-pricing model, ICON and other industry leaders share how they are navigating the friction between global harmonization and local execution including the practical evolution of global pricing floors, the maturing role of AI agents, and the new reality of European access.
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Media article: When your CRO’s AI platform upgrades, who pays for the change management?
This article examines the operations and cost considerations of ICON’s AI platform evolution, following it’s partnership with Microsoft to scale the Orbis platform across clinical trials.
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Media article: ICON names Microsoft tech partner as Q1 results grow analyst confidence
This article reports on ICON naming Microsoft as a technology partner to scale its Orbis AI platform, while highlighting growing analyst confidence driven by improving performance and demand.
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Media article: ACT Brief: ICON-Microsoft AI Partnership, DCT Site Burden, and AI-Enabled Neuroimmune Discovery
This podcast discusses ICON’s selection of Microsoft as a preferred technology partner to scale its agentic AI platform across the clinical trial lifecycle.
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Media article: ICON selects Microsoft to power AI-enabled clinical development
This article reports on ICON’s selection of Microsoft as a preferred technology Partner, bringing Microsoft 365 Copilot, Azure, and AI infrastructure to scale its Orbis Platform and enable AI-driven clinical development.
AI whitepapers
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Webpage: Designing the future: Regulatory readiness for next-generation AI-enabled software as a medical device (SaMD)
This whitepaper, the final in our series on AI in SaMD, examines how regulatory agencies are responding to the rapid proliferation of AI-enabled SaMDs. Regulators are adapting existing submissions processes and introducing new requirements and medical device developers must be prepared to engage early to optimise their submissions’ chances of success.
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Webpage: Developing AI in SaMD
This whitepaper, the second in our series of three, is intended for medical device developers already exploring the possibilities of using AI within future products. It takes stock of the current landscape in the US for AI-enabled medical devices and offers guidance for scientists and engineers considering developing AI-enabled medical devices.
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Webpage: Decoding AI in software as a medical device (SaMD)
This whitepaper provides a starting point for medical device researchers considering use of AI in SaMDs. It also touches on key distinctions and regulatory pathways for AI in SiMD, helping innovators plan their development of software in a medical device and software as a medical device.
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Webpage: Integrating AI into Clinical Research
In this whitepaper discover how AI is reshaping clinical research and how you can leverage its capabilities to drive innovation and efficiency in your organization.
Get started with AI at ICON
Ready to transform your clinical trials with AI? Contact us today to learn how ICON's AI solutions can accelerate your research and deliver better outcomes.