Introducing ARC360®

Your 24/7 Regulatory Consultant

Implementing clinical trial assays and candidate companion diagnostics in global precision medicine studies can be complex and time intensive with ever-changing IVD regulations.

Since its first publication in 2017 and subsequent date of application in May ‘22, the European Union (EU) In Vitro Diagnostic Regulation (IVDR) brings new requirements that companies must follow, regardless of where an EU patient’s sample is tested. Failure to comply can result in reputational damage, industry fines and delays to clinical development timelines and regulatory approval.

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What is ARC360®?

If you work in precision medicine and clinical studies, then the ARC360® Regulatory Navigator is for you. The online, easy access platform enables an immediate understanding of the regulatory requirements for unapproved in vitro diagnostic tests used for patient selection/stratification, dose adjustments and other patient sample testing in pharma and biopharma trials around the globe.

Key features include:

Access 40+ Central Laboratory and Sample Collection Site (clinical trial) country locations requirements

Understand device safety requirements and event reporting in global markets
Support rapid decision making to accelerate clinical site set up

Detailed information on Regulatory Authority Submission/ Notification requirements inc. submission format and content guidance

Country specific Ethics Committee requirements

SME support, to help accelerate you Dx study site activation and co-ordinate country start up with your trial CRO (Enterprise plan)

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Choose your plan to suit your pocket. From regular to professional and enterprise, you can decide how many seats you want at a budget you can more easily manage.

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Central Lab and Sample Collection Site Intelligence

Many global pharma trials involve shipping samples outside of the countries where the patient sample is collected, to be tested with an investigational in vitro diagnostic device. ARC360 allows you to select your particular scenario from a menu of common practices to tailor reports that are specific to your study needs. Whether you need to understand the requirement for CE-marking, Competent Authority Notification, Clinical Trial Application or Safety Reporting, ARC360 captures the full picture and provides information in easily navigated online reports.

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    Competent Authority

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    Ethics Committee

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    Safety Reporting

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    Links to Legislation

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Stay ahead of today’s regulatory challenges

Join the Pharma and Biotech community already benefiting from the regulatory insights on the ARC360® platform.

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