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: ICON selects Microsoft as preferred technology partner to scale agentic AI platform across clinical trial lifecycle
This article reports on an enterprise-wide partnership that brings Microsoft 365 Copilot, Azure, and Fabric infrastructure to ICON's Orbis platform, supporting AI deployment across study design, site operations, and regulatory workflows.
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Media article: From automation to autonomy: How agentic AI is redefining biopharma's digital workforce
This article will explore the emerging architecture of agentic AI in biopharma: what distinguishes agents from traditional rules-based automation, how multi-agent systems orchestrate work across fragmented environments, and why strong governance and upskilled teams are essential to preventing “black-box” operational drift.
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Blog: Real-time clinical trials: a pivotal shift and a global question
While the FDA’s direction is gaining attention, a more important question for sponsors is emerging: how will this approach translate in a global regulatory landscape?
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Media article: Reimagining vaccine development with AI
Explore how AI is accelerating vaccine development, improving speed, precision, and global readiness.
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Media article: Harnessing AI for more efficient clinical trials
ICON’s SVP of Enterprise AI, Tony Clarke, joined a panel of industry leaders at the recent European Pharmaceutical Review’s webinar, “Harnessing AI for more efficient clinical trials” to share his perspective on how AI is being applied to improve trial efficiency, insight generation and operational execution.
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Media article: AI tools life sciences companies
This BioSpectrum Asia piece highlights the AI tools leading organisations are already putting to work—an important look at where practical adoption is delivering real impact across the industry with contributions from Tony Clarke, SVP of Enterprise AI at ICON.
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Media article: ICON teams with Advarra for integrated, AI-driven site network
ICON and Advarra partnership creates an integrated site-centric system that tackles operational bottlenecks and simplifies study execution, addressing sponsors most pressing challenges.
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Blog: Managing AI model biases in AI-enabled SaMDs
Medical device developers using AI in software as a medical device must avoid AI biases to optimise their SaMDs and limit health disparity perpetuation.
AI whitepapers
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Webpage: Digital Disruption: Surveying the industry's evolving landscape
Download the whitepaper to explore the data from our survey and learn how pharmaceutical organisations can get clarity on the risks and benefits of implementing intelligent solutions.
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Webpage: Applying AI to manage the risks and costs of postmarketing requirements
Our award-winning Cassandra AI system harnesses real world data on drugs and data obtained from the US FDA and EMA postmarketing requirements databases to accurately forecast whether postmarketing studies will be necessary.
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.