Our services

Our team of research specialists provide an end-to-end clinical trials service.

Researchers and industry partners can utilise any or all of the services below:

  • Ethics advice
  • HREC and Governance submissions
  • Response to HREC queries
  • Contract facilitation
  • Indemnity and Insurance
  • Standard Operating Procedures
  • Good Clinical Practice (GCP) training
  • Data Safety and Monitoring Boards (DSMBs)
  • Monitoring and reporting of Adverse Events
  • Annual reporting
  • Breech reporting
  • Corrective and Preventative Action (CAPA) implementation
  • PRIME researcher portal.

  • Database design and build
  • Randomisation service
  • Data queries
  • Data extract, linkage and database integration
  • Data cleaning and preparation for analysis
  • Source data document templates
  • Advice on data management and storage
  • Data sharing
  • Connecting to open science (including standardised open access, machine readable data reporting - STARDIT).

  • Desktop monitoring
  • Risk-based monitoring
  • Preparation for audits and regulatory inspections.

  • Protocol tools and templates
  • Template documents- CV, delegation and training Logs
  • Investigator Site File (ISF) templates
  • Trials Methodology Seminar Series
  • Information on upcoming conferences and events.

  • Set up and review of Investigator Site File (ISF)
  • Creation of investigator training packages
  • Organise and facilitate investigator training
  • Support for the inclusion of CALD communities
  • Advertising and promoting trials
  • Trial registration
  • Monitoring participant recruitment and protocol compliance
  • Organising and hosting events – ie. focus and consultation groups, round tables
  • Archiving of study documentation.