ARC Research Laboratories From lab to life™

Laboratory solutions for early phase precision medicine

Accelerate your journey

ARC Research Laboratories is your one-stop-shop for the highest quality assay development and clinical research testing, taking ownership of manufacturer and sponsor responsibilities for early clinical trial assay performance studies.

State-of-the-art instrumentation to meet your study needs.

Why choose ARC?

ARC Regulatory has a long-standing heritage in Precision Medicine, having supported the clinical development and regulatory approvals of 15 precision therapies globally. With a specific focus on early clinical development, the launch of ARC Research Laboratories marks the evolution of our commitment to the highest quality clinical research, supported by our team of globally renowned experts in regulatory and research compliance for IVDs in precision medicine trials.

Proven Experience in Precision Medicine

Our reputation as the leader in research compliance across regulatory and clinical operations is built on more than 10 years of hands-on experience. With involvement in over 90 precision medicine studies and a track record of successful clinical development, ARC Research Laboratories brings unrivalled expertise and operational rigor to every study, ensuring efficient study timelines and reliable, high-quality, scientifically robust data to support the next phase of your biomarker hypothesis.

Meet the team

What Makes ARC Research Laboratories Different?

Regulatory Excellence: Our team of globally-renowned regulatory experts expedite IVD study approvals in the EU in accordance with Annex XIV of the EU IVDR and the US IDE Regulation.
Good Clinical Practice: Having supported more than 90 precision medicine research studies, ensuring that the central testing has been conducted in accordance with GCP and the study protocol, our clinical operations team are experts in delivering the highest quality research that supports programme decision-making with robust clinical evidence.
Expert-Driven Solutions: Our team combines advanced technologies with deep domain expertise in IHC, PCR, ELISA, and beyond, delivering valid, reproducible results critical for patient selection and demonstrating device performance.
Unmatched Industry Experience: Our extensive background in precision medicine studies and regulatory approvals makes us the trusted partner for your clinical research and diagnostic needs.
Commitment to Excellence: From assay revalidation to device manufacturing and IVD study sponsorship, every step is executed with precision, rigor, and global compliance in mind.

Our Expertise

At ARC Research Laboratories, we offer a comprehensive suite of services tailored to early-phase precision medicine trials and device performance studies:

Diagnostic Technology Expertise: Leverage our in-depth experience in IHC, PCR, and ELISA to deliver assay development, validation, and revalidation across our diagnostic platforms.
Pre-clinical Assay Revalidation: Tech transfer your in house developed pre-clinical biomarker assay to ARC Research Laboratories to generate robust evidence of performance that meets the stringent requirements of the US FDA’s IDE and the EU’s IVDR regulations.
RUO to IUO/IVDR Revalidation: Seamlessly transition research-use-only assays to investigational-use-only and to achieve IVDR compliance for new sample types and indications.
Revalidation of Approved Tests: Adapt and revalidate existing tests for diverse indications, optimizing patient selection and clinical outcomes.
Device Manufacturing & IVD Study Sponsorship: Act as both the assay manufacturer and study sponsor, overseeing performance studies with EU patient samples to ensure that the diagnostic devices in your clinical trials meet regulatory standards.
Health Institution and LDT Assay Transfers: Seamlessly transfer Health Institution or laboratory developed assays to deliver high-quality centralised testing in rare and ultra rare disease research.

Unwavering Quality & Compliance

Our operations are underpinned by a commitment to uncompromising quality and regulatory excellence. ARC Research Laboratories is on track to be CAP CLIA and ISO 17025 accredited, and our assay development and validation processes are GCP compliant with ISO 13485 and ISO 14971. We rigorously adhere to international regulations, including the EU’s IVDR and the FDA’s IDE regulations, to ensure that every test and device study meets the highest benchmarks of performance and safety.