Regulatory Navigator
Streamlining Clinical Trials
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
Video Modal
Study Workspace
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.
- Custom workflows and submission checklists for any territory.
- Access to templates for CPSPs, IBs, site set-up, and country-specific Annex XIV checklists.
- Task assignment with target dates for submission tracking.
- At-a-glance submission progress overview.
- Manage submission deficiencies with custom tasks for collaborators.
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.
- Regulatory Interactions: Detailed information on regulatory authority including submission/notification requirements, format and content guidance.
- Ethics: Country-specific Ethics Committee intelligence.
- Document Resources: Access to templates that meet global regulatory and international standards.
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).
- Trial Coordination & Regulatory Guidance: Receive up-to-date guidance on coordinating country start-up with your trial CRO, along with general regulatory support for IVDs in IND/IMP trials (Enterprise plan).
Covering all major countries
ARC360 provides a one-stop shop for regulatory intelligence and IVD requirements, ARC360 is the first place the team go to because it provides highly detailed information for clinical trials within minutes saving us months of research to support our global strategy.
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.
Video Modal
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.
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.











