Neuroscience Trials Australia

Neuroscience Trials Australia is an Australian-based, not-for-profit contract research organisation specialising in neuroscience clinical research.Our superb range of services will ensure we deliver your project in a cost-effective and timely way.Areas of expertise include stroke andstroke-related conditions, multiple sclerosis,epilepsy, Parkinson’s disease, spinal cord injuries, Huntingdon’s disease, neurosurgery,pain, neuromuscular disease and migraine. As a wholly-owned subsidiary of the Florey Institute of Neuroscience and Mental Health, we have strategic alliances with many therapeutic disease groups and we can provide accessto key opinion leaders, sites and clinical trial expertise through a range of tailored services. Our staff have global management experience in all phases of clinical research including studies sponsored by pharmaceutical companies, the biotechnology industry,granting bodies or institutions and Investigator-initiated studies.


Study feasibility
We routinely produce feasibility reports on site availability, potential recruitment and local treatment standards. We can also produce more complex reports when required.
With our direct access to the therapeutic disease groups, key trial sites and key opinion leaders, we can produce feasibility reports within very short time frames.

Project management
Our project managers are committed to ensure milestones are reached and timelines met.  The project manager serves as your primary point of contact and has direct responsibility for all aspects of the clinical trial. They are fully versed on local regulations and will assist with regulatory requirements when setting-up a study in Australia or in other parts of the world. Our project managers can provide guidance on labelling requirements, import permits and local indemnification and insurance issues.  Neuroscience Trials Australia is a registered enterprise in Australia with the Therapeutic Goods Administration (TGA) and therefore can act as your representative locally. 

We can provide you with the following:

  • Development, guidance and management of your clinical development programme
  • Management of assigned project teams
  • Project status reports and newsletters
  • Management of project milestones and deliverables
  • Project, monitoring, communication and recruitment plan generation and implementation
  • Local regulatory advice
  • Management of third party vendors
  • Management of site/investigator payments and tracking.

Our staff have a thorough knowledge of local regulations and ‘good clinical practice’ processes. We adapt easily to our customers’ needs. We are totally flexible and can
follow your procedures or you can ask us to employ our own – it’s up to you.

We can assist you with:

  • Phases I to IV (in Australia or globally)
  • Site feasibility and identification
  • 'Investigator’ and ‘monitor’ meeting preparation and set-up
  • All types of monitoring visits including site selection, initiation, routine and study-closure visits
  • Local regulatory submissions
  • Obtaining local HREC/EC/IRB approvals
  • Site management
  • Good clinical practice (GCP) training
  • Monitoring, communication and study-plan generation and implementation
  • Query resolution
  • Blinded and unblinded investigational product accountability
  • Subject recruitment plans and implementation.

Medical writing
We provide a comprehensive array of clinical trial-related medical writing services in accordance with applicable regulations and guidelines such as:

  • Investigators’ brochures
  • Study protocols
  • Participant information forms
  • ‘Case report form’ completion guidelines
  • Clinical study reports
  • Policies
  •  Standard operating procedures.

Data Management and Biostatistics
We offer a wide range of services including:

  • Study design
  • Sample size calculations / power analyses
  • Interim analyses and statistical monitoring
  • Writing/reviewing statistical sections of protocols
  • Randomisation schedules
  • Programming of tables, listings and figures
  • Interim analyses
  • Statistical analyses
  • Design of ‘case report forms’
  • Design of database and entry screen and maintenance
  • Data Management Plans
  • Specification of data structures and data handling procedures/validation
  • Validation/Consistency check programming.

The Australian clinical regulatory system is renowned for being fast, fair and accommodating. The system works by a Clinical Trial Exemption (CTX) or Clinical Trial Notification
(CTN), with the vast majority of trials undertaken in Australia falling into the latter category. All trials must have an Australian sponsor.

The sponsor takes overall responsibility for the conduct of the trial and signs either the CTN form or the CTX form.  As Neuroscience Trials Australia is a registered enterprise
with the Therapeutic Goods Administration, we are able to act as the Australian sponsor for customers who do not have a legal entity within Australia.

Safety is paramount during all phases of clinical research.  We can provide the following medical monitoring services:

  • Medical support to sites for study protocol interpretation and subject medical management
  • Medical review and assessment of serious adverse event reports
  • Preparation of serious adverse event narratives for regulatory reporting or inclusion in clinical study reports
  • Assistance with, and participation in, Data Safety Monitoring Boards
  • Timely receipt and processing and communication of initial serious adverse event reports and follow-up to case closure
  • Safety reporting in compliance with local regulatory requirements
  • Preparation and distribution of investigator notification letters.

Our People

Professor Stephen Davis


Stephen Davis is Professor of Neurology, University of Melbourne, Divisional Director of Neurosciences, Director of Neurology and Head of the Stroke Service at Royal Melbourne Hospital. He is Past President of the Stroke Society of Australasia, chaired the 4th World Stroke Congress, and was Chairman of the Education Committee for the World Congress of Neurology 2005. Professor Davis has extensive experience as a member of steering committees of international stroke trials, both industry-sponsored and investigator-driven. He co-chaired a number of investigator-driven trials including the ongoing EPITHET and ARCH trials as well as co-founded the Australasian Stroke Trials Network and Neuroscience Trials Australia. From 2002 to 2005 Professor Davis chaired the Royal Melbourne Hospital Human Research Ethics Committee. He is an Honorary Principal Fellow of the Howard Florey Institute.

He has published over 200 papers, 21 book chapters, and co-authored 2 texts, ‘Interventional Stroke Therapy’ and ‘Magnetic Resonance Imaging in Stroke.’ He has chaired or served on numerous national and international committees. He has extensive experience in cerebrovascular research, with interests in acute interventional therapies, new magnetic resonance imaging techniques in brain ischaemia, as well as secondary prevention and brain recovery. He is a member of six editorial boards including Stroke, Cerebrovascular Disease, Journal of Neuroimaging and Journal of Clinical Neuroscience. He has served on numerous national and international steering committees for acute stroke and secondary prevention trials and is a member of the Steering Committee of the Novo Nordisk F7ICH-1371 trial in intracerebral haemorrhage and Astra Zeneca NXY 059 (Cerovive) in acute stroke.

Professor Geoffrey Donnan

Geoffrey A. Donnan, MD is Director of the Florey Institute of Neuroscience and Mental Health and Professor of Neurology, University of Melbourne, Austin Hospital in Australia. He was co-founder with Professor Stephen Davis of the Australian Stroke Trials Network (ASTN) within which there have been conducted numerous investigator driven and other stroke trials.  He is Past President of the Stroke Society of Australasia and Past President of the Australian Association of Neurologists. 

More recently, he has co-founded Neurosciences Trials Australia (NTA), which incorporates neuroscience interest groups ranging from stroke to migraine and provides coordination and support for commercial and investigator driven clinical trials. His other major interest is the interface between basic sciences and clinical stroke medicine.

Professor Donnan has been involved in a number of international initiatives, including establishment of the World Neurology Foundation and the World Stroke Foundation (Secretary). He has chaired the scientific committee or executive committees of a number of international meetings including the 6th International Symposium on Thrombolysis and Acute Stroke (2000), World Stroke Congress (2000) and World Congress of Neurology (2005) and was co-chair of the Education Committee for the World Stroke Congress, Vienna 2008.

Professor Donnan has published over 400 papers in peer reviewed journals, over 60 book chapters, edited 4 books and has been Lecturer or Visiting Professor in numerous countries.  He has trained a large number of Fellows in stroke neurology who now work throughout Australia and other parts of the world. He has served on many international journal editorial boards including Stroke (Co-Section Editor for Stroke Controversies), Cerebrovascular Diseases (Associate Editor) Lancet Neurology and is currently Editor in Chief of the International Journal of Stroke.

Dr Tina Soulis

Tina is the general manager of Neuroscience Trials Australia, a wholly-owned subsidiary of the Florey Institute of Neuroscience and Mental Health.  Tina drives the clinical development of projects for academic and commercial sponsors.

When planning your clinical trial, you can be assured it will be overseen by one of Australia’s most experienced operators in the field.

Prior to her role with Neuroscience Trials Australia, Tina was the director of clinical development at Acrux Pharma Pty Ltd. She managed the strategic direction, development, co-ordination and reporting of the company’s clinical programs.  She had pivotal involvement in taking a product (Axiron), right through all stages of clinical development and in submission of the product dossier for regulatory approval.    
Tina is an experienced driver of clinical drug development, particularly in the design, management and implementation of clinical trials and has worked as a clinical researcher and in senior roles within the pharmaceutical and biotechnology industry for over 20 years. Her experience encompasses all stages of drug development in many therapeutic areas and geographical regions.
Tina has held senior clinical positions with Kendle (a global CRO) that involved the leadership of projects and personnel for numerous biotechnology and pharma clients. Prior to Kendle, Tina was a post doctoral research manager responsible for a team of scientists developing new drugs for the management of diabetic disease. Tina holds a Bachelor of Science (in Biochemistry and Physiology) and a PhD in Medicine from the University of Melbourne.


Talk to us today and let us help you deliver a cost-effective, reliable and high quality project.  You will be served by industry veterans employed by a highly respected research organisation, the Florey Institute of Neuroscience and Mental Health.

Dr. Tina Soulis
General Manager, Neuroscience Trials Australia
Mobile: +61 429 300 705


Click here to download our brochure