The HRB CRF-C is equipped to work in partnership with industry and provide the infrastructure, facilities and experienced research and specialist support staff to successfully conduct world-class patient-focused research. The HRB CRF-C supports researchers and companies in both the pharmaceutical and medical technologies sectors in developing and delivering cutting edge research in a safe and regulated environment to international standards.
Contracted industry funded research studies may either take place on site, within the HRB CRF-C –and thus within UCC- or off site outside of UCC, typically in HSE medical facilities.
- Commercial studies within the HRB CRF-C:
- In these cases the research contract will be between the Sponsor and UCC,
- the research will take place within the HRB CRF-C,
- the clinical indemnity arrangements that apply will be those that directly relate to conduct of research within the HRB CRF-C and
- an appropriate UCC overhead cost will be directly applied to running costs of the study.
- Commercial studies in HSE Medical Facilities:
- In these cases the research is conducted under a contractual agreement between the Sponsor, the HSE hospitals and individual investigators (consultants),
- the research takes place outside of HRB CRF-C (and UCC) in the HSE hospital
- Indemnity coverage is typically provided by the Clinical Indemnity Scheme
- the HRB CRF-C will on request of the investigator(consultants), support the conduct of the study
In either case the Pharma company sponsoring the study has access to approved patient level data for the purpose of regulatory submission and has full ownership of all intellectual property that results from the study.