Working with us
What can we do for you?
We are supported by the University of East Anglia, Norfolk and Norwich University Hospital Trust and the NIHR. Our remit is to support local and national investigators to deliver high quality trials that answer important clinical questions. Further information about the NCTU is available in our NCTU overview.
Trial activities we will typically be involved in are described below. We can only act as your official Clinical Trials Unit if we have oversight of the main trial activities. Please note that if you only require randomisation and database support, this may be available, depending on capacity at the discretion of the CTU Director. Provision of data services alone does not enable a trial to be an official Norwich CTU trial.
- Design, management, analysis and reporting of complex single site and multi-centre randomised controlled trials (RCTs)
- Preparation and submission of grants for CTU trials
- Study Management/Coordination (including study and participating site set-up, preparation of all essential study documents, regulatory and ethics submissions, preparation of annual reports etc.)
- Data Services including data management, data quality assurance, preparation of CRFs and database programming (set up and maintenance).
- Study monitoring (including development of monitoring plans and remote monitoring).
- Central IMP management including sourcing and re-ordering
- Management and organisation of study related committees and groups: (Trial Steering Committees, Data Monitoring Committees, Trial Management Groups, Investigator meetings, End-point review meetings).
- Regulatory affairs (MHRA inspections, CTIMP studies and regulatory submissions)