Clinical Trials
Complementing our in vitro pre-clinical testing services, the BioMed Centre offers the planning and execution of early stage clinical trials for pilot testing new technologies.
Facilities
- A dedicated clinical facility within the BioMed Centre to treat patients with complications associated with indwelling catheters
- Clinical and administrative staff experienced in running clinical trials
- Access to the research and clinical resources and expertise of the North Bristol NHS Trust
- An extensive network of Community Nurses and General Practices from whom we can mobilise patients for trials
- A database of patients that enables us to identify suitable candidates for trials
- Access to a national network of experts from the clinical, scientific, industrial and user group communities
- Access to people with urinary problems and their carers through our partnership with Promocon
- Links with the NHS: National Institute for Health and Clinical Excellence (NICE), Purchasing and Supplies Agency (PaSA), National Institute for Innovation and Improvement and the NHS Innovations Hubs
- Links with other networking bodies through our partnership with the Medical Devices Faraday and MediWales
Services
- Prepare clinical research protocols that meet individual study requirements
- Obtain clinical and user feedback as part of the trial design
- Prepare and submit applications to the Central Office for Research Ethics Committees (COREC) and the Local Research Ethics Committee (LREC)
- Conduct early stage clinical studies on device prototypes
- Analyse the results and prepare reports
- Submit new technology applications to the Medicines and Health Regulatory Agency
All trials conducted by BioMed Centre are run to ICH-GCP standards and comply with NHS Research Governance regulations. In line with regulatory requirements we are keen to publish the results of all trials. All steps are taken to protect intellectual property rights through confidentiality agreements, and we can offer advice on patenting and design rights.