Facilitation of collaborative linkages

  • Linking of preclinical and clinical researchers
  • Connecting clinical and public health researchers
  • Bringing together research groups with other clinical research units

Research Project Development

  • Identification of sources of funding
  • Assist and support funding application
  • Trial or study design
  • Budget development
  • Conduct feasibility
  • Consumer Representative advice and input

Research Project Set up

  • Protocol development
  • Statistical analysis development and planning
  • Design, development and hosting of trial or study database (remote data capture)
  • Patient information sheets and other study material development and production
  • Consumer Representative advice and input
  • Data capture forms development
  • Questionnaires location, obtainment or development
  • Research sites liaison
  • Assistance with ethical applications
  • Assistance with regulatory approval applications (as applicable)
  • Assistance with local approvals and Māori review
  • Organisation of trial oversight groups (e.g. Trial Management Group)
  • Develop and facilitate execution of contracts and service agreements
  • Trial Master File and investigator Site File production
  • Trial specific manuals, procedures development
  • Registration of research project on publically available database or registry (where applicable)
  • Risk assessment
  • Investigator meeting and site initiation

Research Project Conduct and Management

  • Perform monitoring (risk based) – central and site
  • Randomisation provision
  • Ongoing research site liaison (including newsletters)
  • Ongoing training of research project staff (as required)
  • Adverse event monitoring and reporting
  • Database and data management
  • Statistical analysis and reporting (e.g. interim analyses for DMC, funder etc)
  • Management of oversight committees (e.g. Trial Management Committee)
  • Assistance with report writing (interim, safety, HDEC, Medsafe)
  • Quality assurance (including assistance with audits)

Research Project Analysis, Reporting and Close-down

  • Statistical analysis
  • Final report writing (coordinate and input)
  • Preparation of publications and other outputs (e.g. conference presentations or posters)
  • Closing down of study sites
  • Notifications to HDEC, Medsafe (as applicable), local Research Offices, funder, sponsor
  • Central archiving and assistance with site archiving
  • Consumer Representative advice and input