Flinders Clinical Trials unit

Flinders Clinical Trials Unit provides professional, specialised and patient-centred clinical research capability and support services.

The Clinical Trials team offer clinical research and professional expertise to support and enhance research outcomes. Our team comprises multi-disciplinary specialists ready to help refine proposals, collaborate, upscale, budget, design and deliver impactful clinical research.

We can help you leverage existing strengths and tap into modern approaches to effectively and efficiently develop and implement clinical research into evidence, and support its delivery and translation into improved health services and outcomes for the community.

Our services

Elevate your research with expert services and support.

Our research specialists can assist at all stages of the research timeline. Our services include refining proposals, research design, execution, collaboration, upscaling, and budgeting. We are experts in the delivery of clinical research, ranging from registries and observational work to Phase I - IV randomised controlled trials across a broad range of therapeutic areas.

We provide the gamut of clinical trials and registry support services in a way that allows co-design and uptake to assist with all relevant aspects of research, whether investigator-driven grant funded research, local, national & international trials or registries, or industry-funded studies.

Clinical monitoring is a crucial aspect of clinical trials as it ensures that the trial is conducted in accordance with the protocol, standard operating procedures (SOPs) and good clinical practice (GCP) guidelines. Recently, several of our staff completed the ARCS GROW program, gaining competency in clinical monitoring across all phases of clinical trials. Supported by MTPConnect’s Research Exchange and Development within Industry Initiative, this program is facilitated by ARCS, an Australian based professional organization dedicated to advancing and fostering growth within the healthcare sector.

Research areas

Flinders Clinical Trials Unit is housed within Flinders Health and Medical Research Institute (FHMRI) but supports research across the entirety of Flinders University.

We provide advice, project support and trial-related data services across a wide range of health, medical and public health projects.

How can we help?

Project proposal

Study design
Feasibility
Client liaison
Grant proposal development and review
Budget creation/review
Contract advice

Ethics & Governance

Ethics and governance advice, submissions and query responses
Budgets, insurance, registration and contracts

Project Management

Investigator-driven or industry-sponsored clinical research
Phase I-IV clinical trials
Study feasibility & site liaison
Study/site documentation and management
Regulatory and compliance management (NHMRC, TGA and International Authorities)

Data Management

Study feasibility
Case report forms
Database design and build
Data queries, audits and quality assurance
Trial management systems
Endpoint/outcome adjudication systems

Monitoring

Traditional, risk-based or statistical monitoring
Liaison with clinical event committee, outcome adjudicators or data safety monitoring board

Get in contact with us

Through FHMRI, we will welcome new partnerships and collaborations, enhance our existing relationships, and work with health practitioners and patients to better understand and offer solutions for Australian and global health needs.

Contact our team for general enquiries:

hdct@flinders.edu.au