Your partner for Dx compliance in translational research

IVD/CDx Research Laboratories

ARC offers an end to end service that takes your IVD/CDx from lab to life TM

ARC Research Laboratories uses all of its collective in vitro diagnostic development and validation expertise, and advanced laboratory technologies, to provide the highest quality research support that helps ensure our clients’ expectations are met or exceeded. ARC delivers globally compliant solutions that support the development of advanced in vitro (IVD) and companion in vitro diagnostic (CDx) medical devices

Why choose ARC for your IVD/CDx research laboratories needs

Pharmaceutical companies who develop advanced therapies that rely on identifying key biomarkers to ensure treatment efficacy and patient safety are facing an increasing challenge. The demand for high-quality First in Human (FiH) central testing laboratories can navigate evolving technological, regulatory, and efficiency hurdles, while always putting the patient first, is growing stronger than ever.

ARC’s team of experts – Through assay development ensure it is validated under design controls to a regulatory compliant level, for use in the execution of safe and efficient clinical studies.

What makes ARC research laboratories services different

ARC Research Laboratories provides expert in vitro diagnostic development and validation services using advanced technologies. We deliver high-quality, globally compliant solutions to support the validation of advanced in vitro (IVD) and companion diagnostic (CDX) devices  to deliver consistently on clients’ expectations. Furthermore, our expert team ensures a seamless transition of devices to clinical studies, prioritising patient safety aligned with ARC’s Mission, Vision and Values.

ARC offers:

ARC Laboratories offers customised solutions which have been carefully selected based on market insights. ARC has a niche offering to meet today’s exceptional needs from pharmaceutical customers in precision medicine.
ARC is uniquely positioned to be able to support testing of global samples – EU, UK and RoW (excluding China).
ARC offers an opportunity to partner with a “one stop shop” for end to end support in global IVD/CDx Studies.
Timing is everything in the diagnostic industry. ARC’s efficient processes and dedicated team ensure fast turnaround times without compromising on quality.
ARC Research Laboratories are located in heart of Belfast Titanic Quarter, Northern Ireland and designed and maintained to ensure the continuous integrity and quality of sample management and testing.
ARC laboratories are undergoing ISO13485 and CAP CLIA accreditation and is already in compliance with Good Clinical Practice and ISO20916.
ARC laboratories support supplier, accreditors and BiMO audits/inspections.

ARC's research laboratories services offering

  • Novel and in demand technologies – ARC currently supports qPCR, Immunohistochemistry(digital pathology), ELISA technologies with opportunities to expand and bring technologies customised to today’s client needs.
  • Assay verification/validation – ARC provides assay transfer and enhancement services, upgrading client assays from a research-use-only standard to investigational-use-only, in compliance with regulated product/design control principles (ISO 13485 compliant).
  • First in Human (FiH)/early phase clinical testing for global trials – ARC offers central testing and reporting services for early phase clinical investigations/performance studies with the option for ARC to play the role of the device sponsor. ARC supports site and document management through investigator site file/trial master file management and independent clinical monitoring.
  • Validated ISO13485 laboratory QMS and LIMS system – ARC has robust quality management processes in place for study and documentation management including the swift remediation of non-conformances or CAPAs .
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Get in touch with our expert team today