Your partner for Dx compliance in translational research

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Regulatory Navigator

Streamlining Clinical Trials

In a world of complex interdependent regulations where the gaps in knowledge, capacity and systems make it difficult to keep up with the pace of change. Our platform ARC360 provides a suite of solutions to enable informed decision making, collaborative working and streamlined workflows to expedite your precision medicine pipeline.
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Why ARC360®?

ARC360® an advanced IVD study collaboration platform supported by real-time regulatory intelligence to expedite IVD implementation in global precision medicine trials.

  • Mitigating regulatory risks
  • Leveraging Biomarker and Regulatory teams’ global IVD research knowledge.
  • Expediting Precision Medicine trial initiation
  • Supporting Clinical Trial Strategy development and implementation
  • Cross departmental collaboration tool
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Suitable for small consulting companies and CRO's or small biopharma.

  • Step-by-step workflows for study approval submissions in selected countries.
  • Customisable workflows, tasks, templates, and checklists.
  • Integration of internal QMS and additional process steps.

Central Lab Locations and Sample Collection Sites:

ARC360® allows you to select your scenario from a menu of common practices to tailor reports to your study needs:

  • Comprehensive Coverage: Regulatory intelligence for central labs and sample collection sites in 50+ countries.
  • Global Reporting: Insights into device safety and adverse event reporting requirements worldwide.

SME Support

  • Expert Consultation: Connect with your assigned ARC expert from our team of highly experienced regulatory advisors for ARC360®-related queries and guidance on operational regulatory requirements (Enterprise plan only).
  • Accelerated Decision-Making: Gain expert support to fast-track clinical site setup, resolve unclear or ambiguous regulatory information and streamline study site activation (Enterprise plan).

Covering all major countries

ARC360® Regulatory Intelligence Platform

A truly unique offering powered by the latest technologies and supported by a world-renowned team of regulatory and clinical operations experts, ARC360® is revolutionising the way organisations work and access curated regulatory intelligence for IVDs in precision therapy trials.

Flexible plans

The ARC360® Regulatory Intelligence Platform offers affordable and flexible pricing solutions to accommodate your organisation's needs.

Standard

  • Access to 10 Sample Collection sites
  • Access to 3 Central Lab Locations

Professional

  • Access to all Sample Collection sites
  • Access all Central Lab Locations
  • Access to the project collaboration workspace
  • Full access to premium features

Enterprise

  • Access to all Sample Collection sites
  • Access all Central Lab Locations
  • Access to the project collaboration workspace
  • Full access to premium features
  • Subject matter expert support

Next Steps

Find out more about how ARC360 can help you

1. Schedule a Session

The ARC360® team will contact you to arrange a convenient time for your personalised demo.

2. Product Demo

An ARC360® expert will guide you through the platform, showcasing key features and answer your questions.

3. Q&A & Next Steps

Discuss how ARC360® fits your clinical trial needs and explore the next steps.

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Want to learn more?

Contact our ARC360 Experts

FAQs

On the Regular Plan, your initial selection is fixed for the duration of your 12 month contract and cannot be changed. Please contact us if you wish to upgrade your plan during the contract period. The Enterprise Plan provides your organisation with access to all country information. You are not able to switch from the Enterprise Plan to the Regular Plan part-way through your 12 month contract.

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Get in touch to discuss the ARC360® Regulatory Navigator