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Managing your study

Working with you to run a successful study
Once funding has been secured for a study, the NIHR Newcastle MIC will work with you to manage the operation of the study to ensure that it is delivered to time and budget. The following is a list of the services we can provide:
  • End to end study development and management where required
  • Working in partnership with the Newcastle Clinical Trials Unit (CTU) and the Newcastle Clinical Research Facility (CRF)
  • Full study protocol development and statistical design
  • Preparation and submission of Research Ethics Committee (REC) approvals
  • Assistance with MHRA approval where required
  • Development and generation of patient information sheets, consent forms and test request forms via our 'Work Packet System'
  • Data capture and secure storage via the 'Work Packet System'  
  • Liaison between trial sites
  • Ensuring study staff are trained in the study protocol and test procedures
  • Study progress monitoring
  • Assistance with preparation of interim progress reports to funders, sponsors and regulatory bodies
  • Study reporting
  • Preparation of papers and submission to journals
  • Dissemination of findings - NIHR Newcastle MIC website, newsletters, press releases, conferences etc.