Clinical Studies with IVDS
Get the full picture with Arc360

Welcome to ARC360, a single regulatory resource for ensuring study compliance. Whether you are an IVD study sponsor or an IND/IMP sponsor developing a targeted therapy, ARC360 provides essential, difficult to access regulatory information for common trial scenarios in jurisdictions where patients are being enrolled.

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Accelerate Study Setup

ARC360 can help reduce study start up time by a third.

Don’t waste time, budget and opportunity cost to patient health and business by embarking on studies without the full 360 view of regulatory requirements factored into your plan at the outset.

Access up to date, difficult to source, real time regulatory information for biomarker diagnostics and precision medicine trials.

Gain an immediate understanding of the regulatory requirements for unapproved in vitro diagnostic tests being used to select / stratify patients or to make dose adjustments in pharma and biopharma trials. ARC360’s critical information leads to improved trial planning, smarter study site selection and ensures that the local IVD regulations are understood and considered in planning.

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Tailor your study query to global trial scenarios

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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Reliable, Always up to date information

ARC360 is constantly up to date with information from multiple sources involved in IVD performance studies and global precision medicine trials. ARC Regulatory’s relationships and regular communication with global regulators mean you can rely on us to provide insights to help solve new problems and keep abreast of the latest thinking on topics relevant to our customers.

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Your 24/7 Regulatory Consultant

Regulatory intelligence in the palm of your hand. ARC360 works equally well on your desktop computer, tablet or phone so you can work in the office or on the move.

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