King's Clinical Trials Unit

The King’s Clinical Trials Unit (CTU) helps research teams throughout the country carry out clinical trials safely and to a high scientific standard. It offers a range of services to help ensure the results are accurate and credible. The Unit’s services are available to researchers, throughout King’s Health Partners (KHP) and also across the UK. These include:

Protocol development:

  • Study design
  • Protocol writing

Randomisation:

  • 24-hour Online randomisation
  • Online minimisation

Data management:

  • Data management plan preparation
  • CRF creation
  • Database design
  • Web based remote data entry system
  • Integrated data validation checks
  • Data query management
  • Report preparation

Pharmacovigilence:

  • SAE report management
  • Annual safety report preparation

IMP Management

  • IMP supply advice
  • Costing IMP supply
  • Planning study requirements

Trial management:

  • Ethics applications
  • Annual progress reports
  • MHRA applications
  • Contracts management
  • Site initiation visits
  • Monitoring services
  • Report preparation
  • Trial master file management

Statistical services:

  • Sample size calculations
  • Response to reviewers
  • Report preparation
  • Statistical analysis
  • Contribution to primary papers

Education / training:

  • Trial manager supervision
  • Data manager supervision