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