CTU Piechart

Local investigator-led trials

At ARCTU, we aim to support investigators through each step of the clinical trial lifecycle. We offer investigators the support to take their study from a basic idea and develop it into a well-designed study. An investigator can be anyone working in a clinical environment (eg doctors, nurses and allied health professionals).

Trial coordination and management

  • Protocol design
  • Development of supporting documents (eg consent forms, PIS, GP letters etc.)
  • Potential funding identification
  • Gaining peer review
  • Funding applications
  • Trial costing
  • Budget management
  • Preparation for NRES application
  • Management of IRAS submission
  • CTA submission
  • Site identification and feasibility
  • Site selection and initiation visits
  • Creation and management of trial master files
  • Trial oversight and management
  • Management of trial amendments
  • Trial reporting
  • Site close down and archiving

Data management

  • Trial randomisation
  • Case report form (CRF) design
  • Electronic data capture (EDC) database development
  • Data entry, validation and management


  • Trial design
  • Sample size calculations
  • Statistical plan development
  • Reporting to trial committees
  • Data analysis, interpretation and reporting

Clinical trialists

  • Advice on trial design
  • Protocol development
  • Chief Investigator support
  • Trial committee guidance