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: Interview series: Part 1 of 5 - Rethinking site activation to cut startup timelines
How contract standardisation, proactive budget alignment, and AI-enabled negotiation tools can reduce site activation delays and turn agreements into strategic accelerators.
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Media article: Interview series: Part 2 of 5 - Closing communication gaps during study startup
Why persistent communication breakdowns between sponsors, CROs, and sites undermine startup efficiency—and how bidirectional, site-informed engagement models can improve collaboration and momentum.
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Media article: Interview series: Part 3 of 5 - Applying AI to reduce administrative burden without losing the human touch
How practical AI applications can streamline contracts and startup workflows while preserving the central role of investigators, site staff, and patient relationships.
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Media article: Interview series: part 4 of 5 - Why startup timelines are worsening – and how to reduce the trend
The operational pressures driving longer activation timelines, from protocol complexity to site competition, and how earlier, more flexible site engagement can restore momentum.
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Media article: Interview series: Part 5 of 5 - Centering site experience to accelerate site activation
How sponsor and CRO practices that prioritise site needs, clarity, and partnership can strengthen trust, sustain momentum, and speed activation.
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Media article: Examining the growing delays in clinical trial start-up
Brian Mallon discusses the increasing timeframe from site selection to full activation, including the issues contributing to the delay and measures to address them.
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Blog: From AI ambition to real world impact
AI in pharma is stalling due to poor data foundations. Discover what makes healthcare data AI-ready—and how Symphony Health, an ICON plc company, delivers the solution.
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Media article: Next-generation modalities, precision trials, and AI-driven breakthroughs in oncology
The panelists discussed promising scientific and strategic pathways in oncology, including next-generation therapeutic modalities, precision trial strategies, AI applications with demonstrated and measurable impact, regulatory and market readiness, and collaborative models for accelerating early-phase oncology programs.
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.