Clinical Trials Unit

Innovation and medical devices

Healthcare professional adjusting a smartwatch that a patient is wearing to allow for remote monitoring of vital signs

At ARCTU, we specialise in designing and delivering studies that generate credible, proportionate clinical evidence for technologies at every stage of development.

Working alongside the Centre for Biomedicine and Health Innovation, Biomedical Engineering Research Group, Arise Innovation Hubs and NHS regional partnerships, we're part of an integrated ecosystem that takes technologies from bench to bedside.

How we can support you

What we offer

  • Clinical investigation design in accordance with ISO 14155
  • Risk classification review and proportionate study design
  • Protocol and Clinical Investigation Plan (CIP) development
  • Ethics submission and regulatory affairs support
  • Device deficiency and serious adverse event reporting
  • Clinical Evaluation Report (CER) input
  • Post-market clinical follow-up (PMCF) studies

What we offer

  • Evidence planning using the NICE ESF tiers
  • Diagnostic accuracy and algorithm validation studies
  • Usability, acceptability and human factors evaluations
  • Randomised evaluation of digital interventions
  • Bias and fairness assessment in AI diagnostic tools
  • Evidence for NHS procurement and HealthTech navigator approval

We're experienced in surgical trial designs including the IDEAL framework, minimisation, cluster and adaptive approaches.

  • IDEAL framework application
  • Cluster randomised and stepped-wedge designs
  • Learning curve analysis and operator stratification

A five-stage pathway from concept to NHS adoption, designed specifically for health technology startups. Linked to Arise Innovation Hubs for business development and the Centre for Biomedicine and Health Innovation for translational science.

Pragmatic trials, implementation science studies, health technology assessments and post-adoption surveillance studies, delivered through established NHS Trust relationships across Cambridgeshire, Essex and Hertfordshire.

  • Pragmatic and real-world effectiveness trials
  • NHS procurement and commissioning evidence packages
  • NICE appraisal submission support
  • ICS research embedding and NHS partnership engagement

We help you build the evidence that regulators, commissioners and patients actually need – not just the evidence that is convenient to collect.

  • MHRA regulatory process advisory
  • Health economics advisory
  • Stakeholder acceptability and human factors

Read more about what we offer.