Study design
The CRF Director and Head of Clinical Studies are able to provide advice on study design, including:- Design and implementation of early phase clinical trials, in particular first-time-in-human and mechanistic studies
- Selection of the most appropriate patient populations
- Development/validation of marker endpoints
- Expertise on access to experimental medicine tools
Statistical Support
The CRF employs a 0.2WTE statistician to provide support on Imperial College London sponsored studies. This support is subject to availability and workload.
We are able to offer support in the following areas:
- Choice of design
- Sample size estimation
- Randomisation
- Data analysis of studies
Regulatory Support
The CRF focuses on science-driven, investigator-led, academic and commercially-sponsored studies, both single and multi-site. In addition to supporting timely and cost-efficient implementation of studies, the CRF regulatory staff can help with the following:
- Submission to the CRF Protocol Review Board (PRB)
- Development of study related documentation including protocols, participant information sheets, consent forms, GP letters and case report forms
- Research Ethics Committee submissions
- MHRA applications
- R&D approval
- TMF/ISF set up and maintenance
- Project Management
- Data Management
- Monitoring of Imperial College London sponsored clinical trials
