Health Data and

Clinical Trials

Health Data and Clinical Trials (HDCT) provides professional, specialised and patient-centred clinical research support services to researchers.

HDCT brings together more than 70 years of clinical trials and health data expertise to support researchers and enhance research outcomes. Our team comprises multi-disciplinary specialists ready to help researchers refine proposals, collaborate, upscale, budget, design and deliver unique clinical trials and health data science.

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 unique clinical trials and health data science, ranging from registries and translational 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 help you with all relevant aspects of your research, whether self-driven, collaborative and external investigator grants, local, national & international trials or registries, or industry-funded studies.

GET IN TOUCH

Our team is on hand to help with the wide range of research support services and research collaborations. To help us, please complete the request form with as much information as available about your project and the areas of support you are interested in.

For general questions, you can contact email hdct@flinders.edu.au. Please note, filling out a request form will fast track your enquiry.

Submit support request

How can we help?

Project proposal

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

Ethics & Governance

HREC and governance advice
Ethics and Governance submissions and query responses
Phrasing and terminology
Budgets, indemnity and contracts
Data sources and custodians
Attachments and processes

Project Management

Investigator-driven
Industry-sponsored
Phase I-IV clinical trials and randomised controlled trials (RCTs)
Study feasibility & site liaison
Clinical registries and learning health systems
Study/site documentation and management
Regulatory and compliance management (TGA and International Authorities)
Clinical study reports

Data Management

Pilot data/study feasibility
Audits and quality assurance
Dataset design and build
Data queries
Data extracts and linkages
Electronic data foundations
Virtual clinical registries
Learning Health Systems
Trial management systems
Endpoint/outcome adjudication systems

Monitoring

Traditional monitoring
Risk-based monitoring
Statistical monitoring
Local and national monitoring

Analysis

Liaison to

Statisticians
Health economists
Epidemiologists
Clinical event committee adjudicators
Data safety monitoring board members

Innovative Upscaling

Upscaling proposals
Trials sizes
Research networks
Data and outcome collation

Consumer Engagement and Knowledge Translation

Creation/liaison with consumer engagement board
Real-life translation/policy expertise

Resources

Additional personnel capacity
Collaborators and networks
CEC and DSMB arrangements
Health data extraction and linkage, monitoring

Regulatory involvement

Working in compliance with:

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), including ICH GCP (Good Clinical Practice)
Declaration of Helsinki
Council for International Organisations of Medical Sciences (CIOMS)
Therapeutic Goods Administration (TGA)
National Health and Medical Research Council (NHMRC)
National Statement on Ethical Conduct in Human Research
Medicines Australia
Department of Agriculture, Water and the Environment (import customs)
National Association of Testing Authorities Australia (NATA)
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
International Air Transport Association (IATA)
Australian Health Practitioner Regulation Agency (AHPRA)
Medical Dictionary for Regulatory Activities (MedDRA)
Food and Drug Administration (FDA)

GET IN TOUCH

For general questions, you can contact email hdct@flinders.edu.au. Please note, filling out a request form will fast track your enquiry.

Submit support request

RESEARCH AREAS

HDCT supports research across the entirety of Flinders University, in addition to the three themes of Flinders Health and Medical Research Institute - Clinical Translation, Healthy Communities, and Molecular Biosciences.

We provide education, leadership support, advice, project support and data services across a wide range of medical and public health projects, including:

A.I
Anaesthetics
Cancer
Cardiac
Cardio-Oncology
COVID-19
Cystic Fibrosis
Dementia

Devices
Digital Health
ENT
Frailty
Haematology
Health Economics
Heart-AI
Hernia
Imaging

Mental Health
Microbiology
Neonates
Nephrectomy
Neuro-surgery
Ophthalmology
Palliative
Pancreatic
Pharmacology

Pharmacy
PHOCQUS
PTSD
Rheumatology
Rural and remote health
SA-NT 10,000
Sleep
Surgery

Our collaborations

Our collaborations span Flinders University researchers, NHMRC/MRFF/NIH grants, not-for-profit charities, education, industry and investigator trials. We are committed to sharing our unique research skills and services to maximise research impact.

Our research contributions include:

Clinical Research Organisation: local, state-wide, national and international investigator & industry trials
Bespoke database builds, CRFs, surveys, and reporting, such as for cardiac, cancer, and rheumatology studies.
Data design, harmonisation & cleaning, such as for pregnancy and pancreatic, and health economic research.
Grant and industry budgets, such as for COVID-19, lymphoedema, and pharmacological studies.
Ethics and governance applications, such as for healthy ageing and mental health research.

“

I was impressed by the rapid response, professionalism and friendly advice provided by the Health Data and Clinical Trials team – they really rolled up their sleeves entering data and guiding me through what can be a complex system. We got there in the end with ethics approval, Site Specific Approval and ANZ Clinical trials registration. I couldn’t have done it without them!

Clinician Researcher

“

The Health Data and Clinical Trials team is doing an exceptional job in supporting Researchers at Flinders to take on big data projects. [They] worked closely with me to develop the datasets to meet the strict specifications ... as part of a larger nation-wide Collaborative project. The team members are approachable, and their professionalism, led by Erin, is outstanding.

Clinician Researcher

“

HDCT provided invaluable advice on study design and a grant application for a clinical trial. While I have a reasonable knowledge about trial design, I was not confident about all aspects and wasn't aware of the latest techniques. The advice from the HDCT helped me to design a rigorous trial and assisted in budget preparation.

Clinician Researcher Grant proposal advice from HDCT

“

HDCT provided an excellent service to help us set up our MRFF RCT. They are knowledgeable, efficient and helpful. They are an amazing resource for clinical investigators on the Flinders campus.

Clinician Researcher MRFF RCT support from HDCT

“

Just want to drop a note to say what a fantastic [clinical trials education] session it was few days ago – it was crisp, clear, concise, and informative!

Education session attendee Research & Grants Support from HDCT

Hosted by HDCT:

Health Data and Clinical Trials lead

Dr Erin Morton

Dr Morton is a multi-centre clinical trial management specialist, enabler, and implementer of research translation locally, nationally, and internationally. She has over 20 years of clinical trial expertise varying across the full gamut of clinical trials from Phase I to Phase IV, and in roles including ethics specialist, clinical research associate (monitor), national project manager, study coordinator, data manager, pharmacy technician, laboratory technician, pharmacokinetic statistician, operations manager (including contracts and budgets), and Investigator.

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