Why Australia

Australia is the ideal place to conduct your clinical research

43.5% tax rebate on
clinical trial spend

The Australian Government’s Research and Development Tax Incentive has made Australia a very attractive destination for clinical trials.

Australia offers the world’s most attractive cash benefit to companies with an aggregated turnover of < $20 million. You can spend almost double on your clinical program in Australia and recover up to 43.5 cents for every dollar spent.

Learn about the benefits of the R&D Tax Incentive, what it is and who should apply, through this short animation video.

 

 

Speedy start-up and fast
regulatory process

A distinct advantage to conducting clinical research in Australia is the expeditious regulatory environment:

  • Clinical trials can start without having an IND, saving up to a year in regulatory timelines and considerable costs.
  • Australia’s TGA requires only notification of trials and defers responsibility to the HREC (IRB) resulting in faster start-up. 
  • Medical device trials in NZ only require HREC/IRB approval.
  • Full GMP material is not mandated for Phase I clinical trials. 

All the above means study start and the Site Initiation Visit (SIV) can be achieved in 5-6 weeks.

We act as your
local sponsor

The Therapeutic Goods Administration (TGA) mandates that an Australian entity sponsor all clinical trials.  

NTA can act on your behalf as the local Australian sponsor for overseas entities and be responsible for: 

  • Site contractual arrangements 
  • Indemnity and site payments 
  • Financial disclosures 
  • Source competitive clinical trial insurances 
  • Safety reporting to the TGA 
 
 
 
 
Quality assurance

NTA is committed to ensuring highest quality conduct of clinical studies in accordance with Good Practices (GxP).

NTA’s Quality Management System includes:

  • Annual risk-based internal audit program
  • Vendor audits 
  • Risk-based vendor assessment and management
  • Training matrix & training oversight
  • Quality issue/complaint management/CAPA
  • Quality/compliance assistance with:
    • Monitoring activities
    • Investigational product
    • Study tools & documents
    • GCP training
    • Validated computerised systems
    • Study deliverables: protocols, CRF’s/eCRF
    • GCP compliance questions/issues
Globally accepted data

NTA data management is familiar with the nuances of neuroscience clinical trial datasets. We provide accurate and precise end-to-end data management services and deliver world class globally accepted data for TGA, FDA and EMA review.

Unique alliances

NTA is located in the health and academic precinct next to the Melbourne CBD.

NTA partners with The Florey Institute of Neuroscience and Mental Health, the largest brain research institute in the southern hemisphere, which facilitates a unique professional network.

NTA has direct access to therapeutic disease specialists, key opinion leaders and clinical trial sites that collectively enable us to deliver quality clinical trial services with strong recruitment outcomes.

 

I have worked with NTA on a number of investigator led clinical trials over many years. Their team of project managers and coordinators have been experienced, proactive, responsive, and highly organised. These attributes are critical to the success of such studies.
A/Prof Nawaf Yassi, Neurologist
Royal Melbourne Hospital, Joint Lab Head – WEHI

READ MORE TESTIMONIALS

Thinking Globally ~ Acting Locally