Technology stage: I have already demonstrated feasibility and/or have some clinical data. I would like to generate evidence to support NHS (or other healthcare system) uptake and/or evidence required for regulatory purposes.
Our offering:
- access to academic, clinical and industry collaborators and funding applications
- support for funding and regulatory applications, and project management support
- access to study design, regulatory, manufacturing, market access and health economics expertise
- if your technology has regulatory approval, our clinical trials research unit can design a study to test against the current standard pathway;
- if you do not have regulatory approval or wish to use outside of approved indication then we can also help to obtain the required approvals
- opportunity for patients and the public to provide input for study design, to participate in clinical trials, and to disseminate study information
- Environmental impact and carbon emissions should be considered at the core of product and business development. Health technologies are required to demonstrate their carbon impact and therefore need to evaluate and quantify their carbon emissions (scope 1, 2 and 3). We can provide support and training in this area.
Supporting facilities:
- NICHE-Leeds – providing support to develop action research approaches to care
- Centre for Computational Imaging and Simulation Technologies in Biomedicine – digital evidence generation using in silico trials techniques
- RCS Eng. Surgical Trials Centre – methodology expertise from early proofs of concept through to final-phase safety and effectiveness trials.
- Leeds Institute for Data Analytics – effective use of vast data collections to drive research, policy development and public good initiatives.
- NIHR Leeds Clinical Research Facility – high quality early stage and experimental clinical trials.
- Northern Pathology Imaging Co-operative (NPIC) – deploying digital pathology in the NHS and using it to develop artificial intelligence to improve diagnosis.
Next steps: Contact us on hrc-surgical@leeds.ac.uk to discuss your requirements.
Useful links
NHS DigiTrials – data services to support clinical trials.
NIHR Leeds Clinical Research Facility
Medtech Early Technical Assessment (META) Tool
NIHR Innovation Observatory – NICE will only consider reviewing a technology once it has first been through an initial filtering process managed by us at the NIHR Innovation Observatory.
Understanding Health Economics
NICE: Evidence standards framework for digital health technologies