Creation of a world-leading IVD laboratory service in Northern Ireland

In Vitro Diagnostics (IVDs) are an essential element of Precision Medicine. When a new drug is being developed for a condition such as cancer, an IVD is often required in order to support the selection of the most appropriate clinical trial subjects, and/or as a measure of the effectiveness of the drug. Driven by global regulatory authority regulations, these IVDs are increasingly required to have undergone significant performance testing, and their usage within a clinical trial must be conducted and monitored in a compliant manner, to ensure the highest quality clinical research for improved patient outcomes.

Since its inception, ARC's team of IVD and companion diagnostic (CDx) regulatory experts, led by the company's founder, Seamus Kearney, have supported pharmaceutical and biotech R&D companies in their quest to find kinder, more effective patient treatments, via provision of expert consultancy to guide organisations through the complex overlapping regulations for investigational devices used in clinical research, reducing time-to-market of new CDx devices and corresponding therapies.

However, based on insights received from our existing client base, it has become apparent that existing laboratory service offerings for IVDs are not fit-for-purpose. ARC has therefore taken the opportunity to acquire a laboratory at the company's headquarters in Northern Ireland, with the intention of providing a high-quality, technologically competent service, which will address the challenges facing IVD manufacturers globally.

There is a range of services which ARC could offer the IVD community from its new laboratory. Therefore, the aim of this 6-month project is to conduct market discovery work with key potential clients to confirm the precise unmet need of the market, so that ARC's laboratory services offering can be tailored to match appropriately. This market research will be split in to two phases - an initial scoping exercise, followed by an in depth face-to-face focus group. The outputs from the research will be utilised to drive the design of ARC's novel service offering.