Services

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 (e.g. doctors, nurses and allied health professionals).

Trial Coordination and Management

  • Protocol design
  • Development of supporting documents (e.g. 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

Statistics

  • 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