Flinders university Trials RESEARCH unit

The Flinders University Trials Research Unit partners with researchers, clinicians, and academics to deliver high-quality research trials. We work across colleges and disciplines, including (but not limited to) public health, medical sciences, engineering, psychology, social science, and digital interventions.

Collaboration and partnerships with external research groups, individuals, and industry are welcomed.

Our team of multi-disciplinary academics and trial specialists are ready to provide tailored input and support across all stages of the research lifecycle, utilising our experience and expertise to enhance research outcomes. We can help you leverage your existing strengths and tap into modern approaches to develop and implement your trial effectively and efficiently.

Our services

No matter the size of your trial, elevate your research by collaborating with our expert trialists.

Our team consists of trial academics, project managers, data managers, clinical research coordinators, a registered nurse, project officers, statisticians, and health economists. Our research specialists can assist at all stages of the research timeline.

Our expertise covers the refinement of trial grant proposals and related budgets, trial design, through to trial conduct. We have experience across a broad range of trial phases, designs (including effectiveness and implementation trials), and fields of exploration, whether investigator-led grant-funded research, local, national, and international trials, or industry-funded trials.

How can we help?

Project proposal

We can contribute right from the conceptualization of the research question, using standard frameworks to choose a suitable trial design, develop a protocol (including a sample size estimation), and develop the statistical analysis plan (including any health economic analyses required).
Creation or review of a budget for the trial.

Ethics, regulatory & governance

Development and submission of trial-related documents for ethics, governance, and/or regulatory approval (where required).
Trial registration.
Advice/assistance with trial-related insurance and contracts.
Management of trial-related governance groups.

Project Management

Assessment of study feasibility.
Site liaison (for trials with multiple sites).
Development and/or management of study/site documentation.
Ongoing regulatory and compliance management (NHMRC, TGA and international regulatory authorities).
Full trial project management, including recruitment of trial-specific staff.
Clinical support.
Collection, processing. and storage of trial-related biological samples.
Access to clinic space for conduct of trial visits.
Creation and/or liaison with a data safety monitoring board (where required).

Data Management

Creation of data collection tools (case report forms and surveys).
Database design and build.
Management of data queries.
Audits and quality assurance.
Endpoint/outcome adjudication systems.
Statistical expertise, including tailored development of statistical analysis plans and independent randomisation.
Health economics expertise.

Quality Assurance

Traditional, risk-based, or statistical monitoring.
Auditing.

Our location

The Flinders University Trials Research Unit is part of the Flinders Health and Medical Research Institute (FHMRI), College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia. The Unit is physically located on Level 4 (East end) of the Health and Medical Research Building (HMRB), Bedford Park Campus, Sturt Road, Adelaide.