Your preferred partner in IVD and CDx regulatory compliance.Ensuring peace of mind in translational biomarker 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 IVD and companion diagnostic (CDx) regulatory 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 complex overlapping regulations for investigational devices used in clinical research, reducing time-to-market of new CDx devices and corresponding therapies

Our Services

Regulatory

Partnering with you through intricate global diagnostic regulations.

Clinical

Guiding you through every phase of IVD development and CDx studies.

Quality

Covering QMS Auditing, Quality & Risk Management.

Training

A blended learning approach to complement your company's learning needs.

CRO

Guiding you through strategy to delivery of your project.

IVD Clinical Study Sponsor Delegation

Acting as your trusted sponsor to seamlessly initiate and manage your FiH study.

The industries we support

At your side throughout your clinical development journey

At ARC, our industry leading team recognise the need for a personable, collaborative and strategic approach to client engagement when working on complex precision medicine and CDx programmes.

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

From Lab to Life™

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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 clinical trial assays (CTAs) used in precision medicine trials.

Pharma

Diagnostics

Providing expert guidance and resources to diagnostic companies to meet your manufacturer and sponsor obligations, including full service CRO support for clinical performance studies.

Diagnostics

Startups

Developing tailored regulatory strategies and support for start-ups and small businesses, ensuring a clear roadmap to compliance and commercialisation at all stages of the product development lifecycle.

Startups

Laboratory

Outsource your IVD analytical validation studies at our partner laboratory. Access our training resources for GCP, IVDR Article 5(5) (the In-house exemption) and clinical investigations/performance studies. Implement an ISO 17025 or 15189 QMS with support from our team of quality assurance experts.

Laboratory

Digital Solutions

ARC has a range of SaaS digital products to enable and expedite your compliance. From the ARC360® Regulatory Navigator, developed to provide the requirements for utilising IVDs/CDx in precision medicine clinical trials to the ARC360® Laboratory Toolkit, designed to provide a step-by-step guide for EU Health Institutions to comply with IVDR Article 5(5) (the in-house exemption). If you prefer a customised approach, enterprise training is offered across a range of topics to develop and support your diagnostics and translational medicine teams.

ARC360®

Regulatory Navigator

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

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ARC360®

Laboratory Toolkit

A tool for EU health institutions to comply with IVDR Article 5(5) (the in-house exemption).

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ARC360®

Online Training

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

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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.

About ARC Meet the team