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 supporting documents should also be consulted. See the document library.
A valid application should consist of:
- A final copy of the IRAS 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
- Investigational Brochure if required.
Depending on the study R&D and the REC may request further documents.
Further information on contractual arrangements for commercially sponsored clinical trials is available from the R&D department.
R&D finance should be contacted in the early stages of the project for financial advice and processes.