COMING SOON

ARC360® Powered by AURA ai

ARC360® Powered by AURA ai is currently in development. Join the update list for launch news, early previews and product announcements.

Combining the speed of AI with the trust of human expertise, AURA ai will support smarter regulatory monitoring, faster document generation and more consistent oversight across global clinical study delivery.

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AURA AI CAPABILITIES

Built to Support Smarter Regulatory Execution

ARC360® Powered by AURA AI brings AI-supported capabilities into the regulatory delivery workflow, helping teams move from complex requirements to clearer action.

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Regulatory Monitoring

Proactive monitoring of global regulatory changes helps teams stay informed, compliant and prepared for applicable updates.

eQMS System Integration

Embed regulatory intelligence directly into quality workflows to support audit-ready, compliant processes.

Consistent and Accurate Outputs

Validated AI supports traceable, auditable and repeatable outputs that teams can trust every time.

Document Generation

Reduce manual drafting time by generating high-quality draft submission documents ready for expert review.

Human-in-the-Loop Review

Evolving requirements create uncertainty and increase the risk of missed obligations.

Why Regulatory Teams Need AURA AI

Reducing Manual Effort Without Removing Expert Control

Regulatory teams are under pressure to monitor changing requirements, manage complex submissions and maintain clear oversight across multiple countries and stakeholders.

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ARC360® Powered by AURA AI is being designed to reduce time spent on repetitive manual tasks while keeping expert review and regulatory control at the centre of the process.

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  • Faster Workflows
    Support faster movement from regulatory information to usable outputs.

  • Greater Consistency
    Improve repeatability across monitoring, documentation and reporting activities.

  • Trusted Oversight
    Keep expert review embedded in the process to support confidence and control.

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Expert support for regulated teams

Answers to Your Questions

Is ARC360® Powered by AURA ai available now?

ARC360® Powered by AURA AI is an upcoming enhancement to the ARC360 platform. Sign up to receive updates as more information becomes available.

Is AURA ai replacing ARC360?

No. AURA AI is being developed as an enhancement to ARC360, bringing AI-supported capabilities into the existing regulatory intelligence and study delivery platform.

How does AURA ai support regulatory teams?

AURA AI is designed to support regulatory monitoring, document generation, quality workflow integration and consistent outputs, with human-in-the-loop review for trusted results.

Who is this platform update for?

ARC360® Powered by AURA ai is designed for sponsors, CROs, regulatory teams and clinical operations teams managing complex global study requirements.

Connected Programme Support

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ARC brings together regulatory, clinical, laboratory and technology expertise to support diagnostic programmes from development through delivery.

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