Your partner for Dx compliance in translational research

Why ARC? ARC delivers expert solutions to the precision medicine and in vitro diagnostic (IVD) medical device sectors.

ARC’s mission is clear: To be the preferred partner for the global precision medicine and IVD industry, supporting the development of kinder treatments and expediting the highest quality clinical research for improved patient outcomes.

Our team of in vitro and companion in vitro diagnostic regulatory, clinical operations and quality experts, support pharmaceutical and biotech R&D companies in their quest to find kinder, more effective patient treatments.

We integrate with existing teams and other stakeholders, guiding you through the complexity of overlapping regulations for investigational new drugs and devices in clinical research, reducing time-to-market of new medical discoveries.

 

The industries we support

At your side throughout your clinical development journey

At ARC, our leaders are experts in their field and recognise the need for a personable, collaborative and strategic approach to client engagement when working on complex precision medicine programmes.

Our client promise remains our constant: We promote and conduct platinum standard in vitro diagnostic medical device clinical research that ensures the rights, safety and welfare of study participants and that high quality, robust and reliable clinical data is generated that enables sound decision-making for the next phase of clinical development.

From Lab to Life™

Pharma

With a focus on supporting translational biomarkers in early clinical development, plug in to our systems and expertise to fulfil your sponsor obligations for early CTAs. Access our proprietary risk-based monitoring of central testing laboratories across the entire clinical development life-cycle.

Diagnostics

Supplying expert guidance to diagnostic companies to meet their pharmaceutical sponsor expectations. Providing R&D compliance support and your full service CRO for clinical performance studies.

Startups

Crafting tailored regulatory strategies for start-ups, from proof of concept and clinical feasibility to clinical validation and regulatory approvals.

Laboratory

Offering analytical testing capabilities to fulfil clinical trial demands and resources and training across GCP, IVDR and the In-house exemption.

Digital Solutions

ARC has listened to its customer needs and developed a range of SaaS digital products to meet and exceed your expectations. From ARC360's regulatory navigator, developed to understand regulatory requirements for unapproved in vitro diagnostic tests across +50 countries to ARC360® Lab Toolkit, designed to provide a step-by-step guide to align your resources to study requirements, ARC has it all. If you prefer a customised approach, online training is offered to scale up your team to fill knowledge gaps in any easy-to-follow format.

ARC360®

Regulatory Navigator

ARC360

Consolidate and simplify the process for identifying requirements for clinical trials of IVD/CDx.

ARC360®

Laboratory Toolkit

ARC360 mobile device

A tool for labs and health institutions to navigate complex requirements through precision medicine topics.

ARC360®

Online Training

ARC Regulatory online training

Comprehensive clinical, regulatory, and quality online training services through our cutting-edge software ARC360®.

Who are we?

Our Culture. Our People.

We see a future where patient care is kind, available and precise – where all global citizens benefit from the promise of next generation technologies and therapies.

James Lappin ARC Regulatory
14yrs Industry Experience
+50 Biotech Company Partners
50+ Biomarker Programmes
500+ Monitoring Trials

Trusted partner with global ambition

Upcoming Events

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Get in touch with our expert team today