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ARC360 Regulatory Navigator
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Regulatory Navigator

Clinical trial compliance

Benefit from an immediate understanding of the regulatory requirements for unapproved in vitro diagnostic tests, dose adjustments and other patient sample testing in pharma and biopharma trials around the globe.

Why Arc360®

If you work in precision medicine and clinical studies, then the ARC360® Regulatory Navigator is your right hand.

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.

Features & Benefits

Online Access Access 40+ Central Laboratory and Sample Collection Site (clinical trial) country locations requirements.
Global Reporting Understand device safety requirements and event reporting in global markets.
Accelerate Set-up Support rapid decision making to accelerate clinical site set-up.
Authority Detailed information on Regulatory Authority Submission/ Notification requirements inc. submission format and content guidance.
Ethics Country specific Ethics Committee requirements.
SEM Support

Join the Pharma and Biotech community already benefitting

Site Intelligence

Simple online reports capture the full picture

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.

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Customer Story

“At GenDx, we really appreciated the support and guidance provided by the ARC Regulatory team for our projects. Our overall experience has been very positive and the ARC team has shown to be very knowledgeable, responsive and collaborative. A great team to work with.”

Erica Kremer, Director Compliance at GenDx

Flexible plans

Choose a plan to suit you. Decide how many seats you want at a budget you can easily manage. Bespoke plans available, simply get in touch.


Suitable for small consulting companies and CRO's or small biopharma.

  • Up to 10 country-specific requirements
  • Up to 3 central laboratory sites


Suitable for pharma/IVD companies opening clinical sites across the EU and other jurisdictions for precision medicine trials.

  • Unlimited country-specific requirements
  • Access all Central Laboratory Sites
  • Discount for existing customers


Suitable for pharma/IVD companies opening clinical sites across the EU and other jurisdictions for precision medicine trials.

  • Unlimited country-specific requirements
  • Access all Central Laboratory Sites
  • 5 hours SME support per month
  • Discount for existing customers

Compare plans

Standard Pro Enterprise
Single source of regulatory information
Global Clinical Development Planning Tool
Supports rapid decision making to accelerate clinical site set up
Always up to date with the latest regulatory information and community insights
Compliance built-in
Supports planning of the least burdensome approach to your trial
Access requirements for ethical opinion
Understand device safety requirements in global markets
Content access for Central Laboratory Locations




Access information for Sample collection sites internationally




5 hours worth of ARC360® SME consulting support per month
DNA Strand

ARC360 Regulatory Navigator

Request a demo

Why not try before you buy! By reserving a demo at a time that suits you, one of our friendly team can walk you through the user journey when logged in as a subscriber. You’ll see just how easy it is to select your country of choice and determine the most appropriate regulatory pathway, connecting the dots of what and where to submit.  It couldn’t be simpler.  Book your slot now!

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Laboratory Toolkit

ARC360® Laboratory Toolkit covers numerous topics related to IVDR and provides industry specific templates to ensure that you have the correct resources to meet your study requirements.

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Online Training

Explore our online training programs, offering comprehensive education in clinical, regulatory, and quality services for precision medicine companies. Gain industry-specific knowledge for your team and expertise to excel in the rapidly evolving world of precision medicine.

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Get in touch to discuss the ARC360® Regulatory Navigator