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.
FORWARD+
AI-enabled resource forecasting capability that promotes efficient management of staff and operational resources throughout the trial lifecycle.
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.
OMR AI Navigation Assistant
A generative-AI-enabled analytics assistant that transforms operational clinical metrics into actionable business insights for smarter decision-making.
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: AI is already delivering pharma value — and not just in drug discovery
This article highlights how AI is already adding value across pharma beyond headline‑grabbing drug discovery, with ICON leveraging its in‑house and proprietary AI tools—like its One Search site‑selection system, resource forecasting, endpoint strategy analytics, and document management platforms—to improve clinical trial efficiency and address enrollment challenges.
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Media article: Harnessing AI and big data in clinical research
The article explores the evolving role of AI and digital technologies in clinical research, highlighting industry trends, adoption challenges, and the potential for improved efficiency, cost reduction, and accelerated drug development.
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Media article: AI, Big Data, and Digital Disruption
This article takes a look at ICON's recent digital disruption survey which surveys changing attitudes and challenges in digital innovation for clinical research.
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Media article: ICON discusses how AI is changing clinical trial recruitment and diversity
Kathleen Mandziuk, Vice President of eClinical Development & Delivery, offers insights on the persistent challenges of patient recruitment, the revolutionary role of AI and digital tools, and the critical importance of diversity and inclusion.
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Blog: A clinical trial linguist’s perspective on machine translation
Perspectives on what machine translation means for clinical trial translations from an experienced clinical trial linguist.
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Media article: AI-powered precision measures: A golden opportunity for clinical research
As the cost of developing new therapies continues to rise, pharma executives must turn to technologies that drive better insights into de-risked investments and produce operational efficiencies. AI-powered digital measures are being developed and validated to better define disease, patients, and drug efficacy.
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Media article: AI’s transformative role in drug discovery and development
In the Irish Times Life Sciences and Stem supplement, ICON’s CIO Tom O’Leary discussed AI is transforming drug development across a range of specific use cases, from discovery to clinical trials and post-marketing.
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Media article: How AI can manage the risks and costs of postmarketing requirements
Postmarketing requirements (PMRs) for drug development are commonly required to gather data on a product’s longer-term safety, efficacy and optimal use. Carefully applied AI and machine learning offers the potential for better management of PMRs.
AI whitepapers
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.