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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.

ARC360 is revolutionising the way organisations access regulatory intelligence and tailor study specific information and guidance based on how they are using in vitro diagnostics to select and manage patients in the IND trails. A truly unique offering, powered by the latest technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is set to accelerate typical timelines for initiating complex clinical trials.
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Central lab and 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.

Key Features

Detailed Requirements

Requirements for Regulatory Authority Submission / Notification, Ethics Committee and Safety Requirements in global markets.

40+ Countries

Access 40+ Central Laboratory and Sample Collection Site (clinical trial) country locations requirements, saving time by quickly and easily accessing country specific information.

Expert Support

Support rapid decision making to accelerate clinical site set up. SME support, to help accelerate your study site activation and co-ordinate country start up with your trial CRO (Enterprise plan).

Solutions and Pricing

Regular

£1,500/month per user

Access to your choice of central labs and sample site locations. Suitable for small consulting companies and CRO's or small biopharma
(12 month minimum subscription)

  • 10x Sample Site Locations
  • 3x Central Laboratory Locations

Professional

£4,000/month per user

Unlimited access. Suitable for pharma/IVD companies opening clinical sites across the EU and other jurisdictions for precision medicine trials
(12 month minimum subscription)

  • All Sample Site Locations
  • All Central Laboratory Locations

Enterprise

Contact ARC360 Sales Team

Unlimited access with SME support. Suitable for pharma/IVD companies opening clinical sites for trials across the EU and other regions
(12 month minimum subscription)

  • Everything in Pro Package
  • SME Consultant Support

Commonly Asked Questions

Can I amend my plan part-way through my contract?

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.

How frequently is the content updated on ARC360?

As frequently as we receive new information or there are updates to regulation. We clearly time stamp the date of update for every country included on the ARC360 platform. You can always rely on ARC360 having the latest information and if we happen to miss something; we can rely on our contributor community to point out anything that requires our attention. We fact check all suggested updates and if they are correct and useful to the wider community, we will add them to the ARC360 platform.

Which forms of payment can be used for an ARC360 subscription?

We use Stripe to process our payments, they accept most major credit cards. Enterprise plans can also request to be invoiced and pay by BACs or wire transfer.

How secure is ARC360?

ARC360 encrypts data with industry standards including SSL and makes sure it stays protected with 24x7 monitoring. We use 2-factor authentication to ensure your profile and access are secure.

How does the Enterprise plan differ from the Regular plan?

Enterprise offers unlimited central lab and sample site country access and 5 hours worth of SME support per month included. Learn more about Enterprise and request a demo for a complete overview of what it can offer by visiting our contact page and selecting the option to request a demo.

Who in my organisation is most likely to benefit from an ARC360 profile?

There are several functions within CDx and Pharma companies who will benefit from access to the ARC360 platform. This information is primarily aimed at those functions responsible for planning clinical trials with biomarker assays (Clinical Operation and Regulatory). However, Business Development functions within CDx sponsor organisations will also benefit by gaining an understanding of the resource required to meet the local IVD regulatory requirements and the associated costs for this activity.

How do I cancel my ARC360 Plan?

Your ARC360 contract is a recurring 12 month contract. Once you have signed up to ARC360 and selected your plan, you are unable to cancel the first year's contract. You may cancel at any time throughout the initial 12 month period to stop you incurring the cost of a new 12 month contract in year 2. We endeavour to ensure that you make an informed decision before signing up to ARC360, including online and live demos and pre-contract Q&A.

What do I do if I can't log into my ARC360 account?

Visit the contact page and select the option for Technical Support and include your contact details so we can identify you and talk you through unlocking or accessing your account.

What if my 2FA emails are not delivering?

Please reach out to the ARC360 team and they should be able to assist you with this query. Please also check your internal IT procedures to ensure that our emails have not been quarantined through your firewall settings.