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
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