Trial Development
Clinical Trial Development
We can help you to develop a clinical trial.
In conjunction with NIHR Reseach Design Service North East we can assist with:
- identifying the appropriate funding stream(s)
- refinement of research questions
- choosing the most appropriate study design
- trial design
- including an economic evaluation component
- including a qualitative component
- development of participant selection, strategies and sampling
- choosing the most appropriate outcome measures
- planning for compliance with regulatory and governance requirements
- guidance on ethical issues
- guidance on feasibility issues, in collaboration with the NIHR Clinical Research Networks
- IMP procurement, including referral to NHS Trust pharmacy and procurement services
- advice on resource requirements
- distinguishing between research, NHS support and treatment costs
- costing the proposal, in collaboration with University and NHS Trust finance colleagues
- planning and scheduling study timelines and milestones
- advice on the role and membership of Trial Oversight Committees
- Trial Steering Committee (TSC)
- independent Data Monitoring and Ethics Committee (DMEC)
- advice on presentating the application to funders