Orbis multi-agent platform
An intelligence layer that connects expertise, data, and AI across the clinical trial lifecycle.
What is Orbis?
Orbis is ICON’s multi-agent AI platform - the front door to a growing ecosystem of intelligent agents designed to support clinical development end-to-end.
These agents:
- Retrieve relevant information instantly from trusted sources
- Generate high-quality first drafts grounded in standards
- Execute routine workflow steps under human direction
Delivered through a unified interface - and embedded directly into the tools your teams already use - Orbis enables faster, more consistent execution across studies.
Trial set-up: Contract generation
A secure, custom-built AI-enhanced SSU Contract Generation Agent that accelerates Study Start-Up by automatically generating country-specific SSU templates from a negotiated Master Contract. The agent transfers negotiated language and tracked changes into local country templates, significantly reducing manual effort for contract lawyers while enabling fast QC, review and finalisations by SSU legal.
Key benefits:
- Shorter study start-up timelines
- Released legal capacity
- Improved consistency and quality
- Scales without headcount growth
- Audit and compliance friendly
Trial execution and delivery: Contract insights
A secure, custom-built AI-enhanced Contract Intelligence Agent that helps Legal Counsel, Client Contract Services, and Procurement teams rapidly understand, manage and assess contracts, amendments, and releases. As part of the Orbis Contract Intelligence suite, the Contract Insights Agent accelerates contract review, negotiation, and change analysis.
Key benefits:
- Speed up contract review, management and negotiation
- Deliver shorter turnaround times on queries and accelerating reviews
- Check impact of rapid changes
- Support compliance and risk management
Trial execution and delivery and close out
Your teams process expert: secure custom-built AI Agent with deep knowledge of your process documents in Veeva Vault. It delivers fast, accurate answers with citations to the exact source , right when you need them.
Trial Close out
A secure custom-built AI Agent that transforms specifications into production-ready code for the Biostatistics & Programming. Build on the ORBIS platform, Orbis CodeGen accelerates delivery, improves consistency, and reduces manual programming effort – while remaining grounded in approval standards and templates.
Key benefits:
- Faster delivery
- Improved consistency
- Lower risk
- Programmer productivity
Why it matters
Accelerate timelines
Move from hours or days to minutes across core workflows.
Improve quality and consistency
Outputs are grounded in SOPs, templates, and approved standards - with full traceability.
Reduce operational risk
Standardized, AI-assisted workflows help minimise variability and manual error.
Scale without adding headcount
Handle increased study volume and complexity without proportional resource growth.
How Orbis works
Orbis combines three core capabilities:
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Intelligent retrieval
Deep search across SOPs, templates, and knowledge repositories - delivering precise answers with source citations in seconds.
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Intelligent generation
Create first drafts of critical outputs - from pharmacovigilance reports to country contracts and statistical code.
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Task execution
Automate routine steps such as document filing, status updates, and workflow handoffs - with full oversight.
Where Orbis adds value
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Clinical & operational delivery
- Faster study execution with reduced delays
- Consistent outputs aligned to SOPs
- Automated knowledge retrieval
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Biostats & Programming
- Generate SAS and R code from specifications
- Improve consistency and reduce rework
- Accelerate delivery of SDTM, ADaM, and TFL outputs.
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Study Start-up & Legal
- Generate country-specific contracts from master agreements in minutes
- Accelerate review, negotiation, and QC cycles
- Improve compliance and traceability
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Contract Intelligence
- Rapid contract search, comparison, and analysis
- Faster turnaround on queries and amendments
- Improved risk management and compliance
Real impact
- Pharmacovigilance reports: hours → minutes
- Contract generation: up to 60 country templates in minutes vs. days
- Programming: automated spec-to-code acceleration for faster study close-out
Governance by design
Human in the loop - always. ICON experts review, validate, and finalise every output. AI accelerates execution, but decisions remain firmly in human hands.
What’s next
ICON continues to expand Orbis with new agents and capabilities, including next-generation tools to support monitoring, decision-making, and predictive insights across clinical operations.
Discover how AI, powered by Orbis, can transform your clinical development.
Orbis brings multi-agent AI directly into your workflows. Combined with human expertise and oversight, Orbis improves operational efficiency and compliance, accelerating delivery.