ARC360 Earns Gold Level Innovation for Cutting-Edge Technology

ARC is excited to announce that our digital regulatory tool, ARC360TM, has received Gold Level Innovator status through Innovate NI - Northern Ireland Department of the Economy. Keep reading to discover how ARC360 can revolutionise your regulatory compliance, expedite successful clinical validation and deliver improved patient outcomes.

As the life science industry continues to grow and evolve, regulatory compliance is becoming an increasingly difficult to navigate. Fortunately, ARC Regulatory has created bespoke services to help clinical and regulatory teams  navigate this complex regulatory landscape. The ARC360 platform provides a comprehensive suite of tools that allows companies to manage numerous aspects of their compliance program in one place.

In Vitro Diagnostics (IVDs) play an essential role in the detection and diagnosis of diseases, infections, and other medical conditions. As the demand for IVDs grows, so does the need for regulatory compliance. The introduction of the European Union (EU) In Vitro Diagnostic Regulation (IVDR) brings new requirements that companies must follow, and failure to comply can result in reputational damage, industry fines and delays to regulatory approval and market launch timelines. ARC360 hosts numerous geographical regulatory requirements including EU IVDR 2017/746, FDA requirements and RoW regulations in one easy to use platform. ARC360 is split into two bespoke service offerings to cater to the specific needs of our clients.

ARC360 Regulatory Navigator - Our regulatory database of over 40+ Central Laboratory and Sample Collection Site country requirements for IVD/CDx clinical performance/validation studies. This tool helps companies navigate the complex and ever-changing regulatory landscape by providing easy access to difficult to source information such as submission to National Competent Authority and Research Ethics Committees as well as requirements for Safety Reporting and links to applicable country legislation, submission portals and and guidance provided in an easy to navigate platform.

The ARC360 Regulatory Navigator enables an immediate understanding of the regulatory requirements for unapproved in vitro diagnostic tests used for patient selection/stratification or dose adjustments in pharma and biopharma trials. By providing difficult to access, real-time information on regulatory, ethics and safety reporting requirements for study sponsors and investigators, in jurisdictions when patients are being screened or managed, ARC360 facilitates improved trial planning, smarter study site selection, and ensures that local IVD regulations are understood and considered in the planning process.

ARC360 Laboratory Toolkit - Aimed at EU health institutions and commercial research laboratories seeking to understand the In Vitro Diagnostic Regulation (IVDR) requirements for their labs. This service provides comprehensive learning modules for EU Health Institutions to comply with the IVDR In-house Exemption described in Article 5(5), including topics such as ISO 15189, ISO13485, Medial Device Risk Management in accordance with ISO 14971, Intended Purpose Performance Evaluation, GSPR Checklist and many more resources to expedite your laboratory’s achieve compliance.

Our laboratory toolkit provides a comprehensive learning structure that includes links to applicable legislation, interactive video explainers, "Confirm Your Knowledge" quizzes, and industry-specific templates. With these resources, ARC360 offers a robust platform for your labs to expedite compliance and participate in global research programmes that deliver improved patient outcomes and a kinder treatment paradigm.

Key benefits of ARC360 is its ability to automate many of the compliance processes that can be time-consuming and complex. For example, the platform can automatically generate regulatory reports and track regulatory changes, freeing up valuable time for teams to focus on other aspects of their device study. In addition to these features, ARC360 also provides access to a team of regulatory experts who can provide guidance and support on compliance issues depending on the subscription level chosen. This is particularly valuable for companies that may not have the resources to hire full-time regulatory affairs resources or that need support with specific queries.

The gold accreditation awarded by Innovate NI is a testament to the unique service offerings that the platform provides to the IVD and precision medicine industry. With its comprehensive suite of tools, ARC360 is a valuable resource for any company looking to ensure regulatory compliance, expedite study set up, easily navigate IVDR and global requirements for clinical performance studies and provide ongoing access to experimental therapies for the betterment of patients and their families.

Stay ahead of the regulatory curve with ARC360 and find out how our product can support your go-to-market strategy by scheduling in a demo with our team. Alternatively contact our team of experts via email for any other questions.