Commercial studies can be sponsored and funded by pharma companies or Biotech industry. Where a research project, for example a commercially sponsored clinical trial, requires a formal agreement to be signed by the Trust, R&D approval will not be provided until the terms of the agreement have been finalised. The Principal Investigator or Sponsor should therefore provide the R&D Department with a draft agreement, and the study protocol, as early as possible in the application process to avoid delays in obtaining R&D Approval. All relevant support documents should also be consulted. See the Document Library
A valid application should consist of:
- A final copy of the IRAS and R&D form
- Research protocol
- All regulatory approvals (e.g. MHRA if required)
- CVs of all investigators
- GCP certificates
- Draft mCTA and study budget negotiation
Further information on contractual arrangements for commercially sponsored clinical trials are available from the R&D Department.
R&D finance Manager should be contacted in the early stages of the project for financial advice and processes.