Clinical trials test new treatments to find better ways to prevent,
detect or treat disease.
What is a Clinical Trial
A clinical trial is any research study that assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
Clinical trials may consist of but are not limited to:
Surgical and medical treatments and procedures
Experimental drugs and diagnostics
Biological products
Medical devices
Health-related service changes
Health-related preventative strategies
Health-related educational interventions
Why do we Need clinical Trials?
Clinical trials are essential to the development of new interventions. For example, we cannot correctly determine whether new medicines developed in the laboratory are effective or safe without clinical trials.
‘Unapproved’ therapeutic goods for clinical trials
Download our ‘Unapproved’ therapeutic goods for clinical trials and learn how Medsurge can help accelerate your product development whilst reducing your time to market.
Clinical Trials Framework
Human Research Ethics Review and Approval (HREC)
HREC must review all clinical trials. The HRECs is responsible for approval of the trial protocol under both the CTN and CTA schemes.
Good Clinical Practice (GCP)
All Clinical Trials must be conducted per the Guideline for Good Clinical Practice.
CTN and CTA trials
There are two schemes under which clinical trials involving ‘unapproved’ therapeutic goods may be conducted
State and territory requirements
Each of the Australian states and territories has separate legislation relevant to the conduct of clinical trials.
National Approach to Single Ethical Review of Multi-centre Research
The National Health and Medical Research Council (NHMRC) established the National Approach.
Registration of trial
The trials must be registered in a publicly accessible database before recruitment of the first participant.
Benefits of conducting clinical trials in Australia
World leader in clinical research
We offer a comprehensive clinical workforce producing high-quality data by its experienced, skilled and accredited research teams.
Throughout Australia, we offer many purpose-built clinical trial facilities that are fully secure and self-contained. These facilities operate 24 hours a day and 7 days per week in some cases.
Efficient ethics and regulatory framework
Research proposals are submitted directly to Australian Human Research Ethics Committees (HRECs), which assume the primary review responsibility for ethical and scientific review.
The review cycle usual takes 4-8 weeks. It is based on submitting a protocol, investigator brochure, and, if required, an independent toxicology report.
The diverse participant recruitment pool
Australia has a knowledgeable and willing population of potential trial participants, resulting in a higher level of research participation than expected from a population of its size.
Investment incentives
The Australian Government offers substantial Research & Development (R&D) Tax Incentive encourages more industry investment in R&D.
Flexibility
Data produced from research studies undertaken within Australia meets global standards and can be used to support international regulatory applications, including the US FDA IND submission.
Market Expansions
Australia’s multi-billion-dollar pharmaceutical market has been growing steadily over the past decade. It’s always worth considering Australia in your global strategy.
Our experience and value
Medsurge has extensive experience accessing, importing and supplying ‘unapproved’ therapeutic goods for clinical trials. Our professional team comprises highly experienced experts and specialists who can provide you with the assistance you require to apply for unregistered medicines approval.