Study design and regulatory staff support

  • Study design

    08_ictem_buildingmisc_24The 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