clinicaltrialsNSW

A joint initiative between the National Health and Medical Research Council and the Department of Industry, Innovation and Science to provide information and resources to consumers, health care providers, researchers and industry about clinical trials.

A dedicated service that the Therapeutic Goods Administration (TGA) offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations.

Represents the discovery-driven pharmaceutical industry in Australia. Its member companies invent, manufacture and supply innovative medicines and vaccines to the Australian community.

The national association representing companies in the medical technology industry. MTAA aims to ensure the benefits of modern, innovative and reliable medical technology are delivered effectively to provide better health outcomes to the Australian community.

A well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), digital health, food technology and agricultural sectors. It has representation in each Australian state, providing a national network to support members and promote the commercialisation of Australian life science in national and international marketplaces.

A professional development association for people working in the development of therapeutic goods. It serves all personnel committed to therapeutics development in Australia. It also provides education and training to industry and non-industry personnel, with its educational events open to members and non-members.

A national peak body supporting and representing the networks of clinician researchers that conduct investigator-initiated or 'public-good' clinical trials within the Australian health system.

A not-for-profit organisation aiming to accelerate the rate of growth of the medical technologies, biotechnologies and pharmaceuticals sector to increase commercialisation, collaboration and establish Australia as an Asia-Pacific hub for MTP companies.

A collaborative of stakeholders, all interested and involved in clinical trials in different ways, with a shared passion for striving for excellence in clinical trials.

Create pragmatic solutions, such as templates, guidance, model frameworks and systems that addresses barriers and issues that are negatively impacting the ability of the biopharmaceutical industry to bring medicines to patients that need them. These solutions are developed collaboratively and can be voluntarily adopted by stakeholders in the clinical research ecosystem.

It is made up of more than 80 organisations from across the clinical trial enterprise. Members include representatives of government agencies, industry representatives, patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.

An Act relating to therapeutic goods in Australia.

Therapeutic goods entered in the Australian Register of Therapeutic Goods (ARTG) can be lawfully supplied in Australia.

In-vitro diagnostic medical devices (IVDs) are, in general, pathology tests and related instrumentation used to carry out testing on human samples, where the results are intended to assist in clinical diagnosis or in making decisions concerning clinical management. A regulatory framework commenced on 1 July 2010 that ensures all IVDs will undergo a level of regulatory scrutiny that is commensurate with the risks associated with their use.

Medical devices are regulated in Australia by the TGA. This includes software and mobile ‘apps’ that meet the definition of a medical device.

An online registry of clinical trials being undertaken in Australia, New Zealand and elsewhere.

A database of privately and publicly funded clinical studies conducted around the world.

The clinical trials search portal provides access to a central database containing the trial registration data sets provided by the registries listed on the right. It also provides links to the full original records.

An investigator can submit to any public HREC in Australia.

The National Health and Medical Research Council (NHMRC) register has over 200 HRECs in organisations across Australia. Registration means that the HREC has notified the NHMRC of its existence and declared that it meets the requirements of the National Statement.

Bellberry Limited is a national, private not-for-profit organisation providing streamlined scientific and ethical review of human research projects across Australia.

It hosts eight HRECs with extensive experience in providing ethics review and has rapid access to relevant scientific experts and specialists for adult early phase clinical trials.

The Sydney Children’s Hospital Network Human Research Ethics Committee is responsible for ensuring the ethical and scientific acceptability of research conducted at sites within the network and other paediatric specific research referred to it by any public health organisation from NSW, ACT, VIC, QLD and SA.

It has extensive experience in providing ethics review and has rapid access to relevant scientific experts and specialists for paediatric early phase clinical trials.

The research and development (R&D) tax incentive encourages companies to engage in R&D benefiting Australia, by providing a tax offset for eligible R&D activities.

A centralised publication of current and future Australian Government grant opportunities and grants awarded.

A not-for-profit organisation and registered health charity who represent the interests of patients, carers and their families in NSW