Implementation of the new Medical Device Regulations has resulted in more devices requiring a clinical investigation prior to CE mark submission. CHEATA can support clinical trials, investigations or performance studies. For clinical investigations of non-CE marked devices, we can review clinical protocols to ensure all requirements for the CE mark are included and we can liaise with the MHRA to obtain a letter of no objection. We have a clinical trials manager who has over 25 years’ experience in running trials at NUH who will ensure the trial runs as smoothly and efficiently as possible.

Clinical trials represent a significant financial investment outlay for a product and we can assist in estimating the costs associated with running a trial at NUH using the NIHR commerical costing tool. This could be used for internal budgeting purposes or could be included in any grant submissions that would cover the cost the clinical study. We work closely with the Research and Innovation Department (R&I) at NUH who facilitate the organisation, hosting and running of clinical investigations and trials within NUH. Their website can be found here.