For industry and sponsors: clinical trials
Clinical trials
The Child and Adolescent Health Service (CAHS) welcomes contact from industry and sponsors interested in working with us to improve health outcomes for children and young people.
CAHS is Western Australia’s leading site for paediatric clinical trials.
We conduct clinical trials across all paediatric disciplines, have world-class facilities and equipment, and a high-performing clinical workforce that is active in research.
CAHS underwent its inaugural assessment under the Australian Commission on Safety and Quality in Healthcare’s National Clinical Trials Governance Framework in 2024. The accrediting body rated CAHS as having ‘developed systems’ – the highest level of maturity.
Clinical Trials Liaison Officer
CAHS has a Clinical Trials Liaison Officer (CTLO), who serves as the primary contact for sponsors seeking to conduct clinical trials at CAHS.
The CTLO will assess the feasibility of running a trial at CAHS and can work with both sponsors and researchers to smooth the startup process.
Sponsors should email the Clinical Trials team to speak to the CTLO.
Research suites at Perth Children's Hospital: Clinic D
CAHS has a dedicated clinical research facility located in Perth Children’s Hospital.
Commonly known as ‘Clinic D’, the centre is a modern, well-equipped area that enables researchers from CAHS, The Kids Research Institute Australia and universities to work together.
Clinic D provides the following facilities:
- 15 standard consultation rooms
- 2 purpose-built rooms – for respiratory and stress electrocardiograms (ECGs)
- 1 treatment room, adjoining a centrifuge and fridge freezer.
Clinic D also houses a laboratory and clinical trials pharmacy.
Suites are available from 8am until 5pm Monday to Friday. Bookings are essential.
Projects must have CAHS governance site approval to access the suites.
Researchers are given specific information about the booking process and requirements for managing research clinic appointments during their local area orientation.
For further information contact the Clinical Nurse Manager Research.
Research Companion
Research Companion is a service offered by CAHS that takes care of the administrative work involved in applying to conduct trials at CAHS.
Sponsors can access this service for a fee. Research Companion expedites the progress of clinical trials through CAHS’ regulatory processes, with smoother startups and competitive ethics approval turnarounds.
Projects using the service benefit from the direct involvement of Research Companion team members who maintain close contact with sponsors throughout the approval process.
Research Companion provides assistance with Human Research Ethics Committee (HREC) and governance approval as well as management support post-approval.
Guide to costs for industry and sponsors
Download A guide to costs and payments for sponsored clinical trials.
This document provides a guide to costs for commercial organisations and sponsors looking to partner with CAHS in conducting clinical trials.
It is designed assist with developing and negotiating clinical trial budgets and is divided into 3 sections:
- overview
- site facilities and support
- standard charges from the CAHS research departments and external vendors.
The list of potential fees is not exhaustive and should serve as a guide only.
Each activity represents a service that may incur a cost.
In developing final fees and budgets for clinical trials, sponsors should consider the actual costs of these services and how these costs will be reimbursed. Some activities may be regarded as standard care and should be identified separately.
Not all activities listed are necessarily relevant to a specific clinical trial or circumstance.
For more information contact the Clinical Trials team.
What are some of the advantages of conducting a clinical trial in Australia?
Australia is home to many high-performing researchers and health professionals, who operate within a modern and well-equipped healthcare system.
Australia offers a stable socio-political environment and has a simple and efficient regulatory system. With one of one of the world’s most multicultural populations, it is also an ideal place for recruiting diverse study samples.
What is the advantage of conducting a study at CAHS?
At the Child and Adolescent Health Service (CAHS) our researchers perform quality, patient-orientated clinical research across all paediatric disciplines.
We also offer dedicated onsite clinical research facilities which are modern and well-equipped.
Can you conduct trials in all fields?
Yes, we conduct trials across all paediatric disciplines and will discuss our capabilities openly and honestly with you from the outset.
Can you help us design a clinical trial?
In commercial studies, sponsors are responsible for designing protocols and other relevant documentation. An inhouse research team is, however, available to support with the design of investigator-initiated trials.
Do you obtain ethics and governance approval for your trials?
Yes, all research projects undertaken at CAHS sites – which include Perth Children’s Hospital, Community Health, Mental Health and Neonatology – must be submitted, reviewed, and approved by a recognised Human Research Ethics Committee (HREC) and our own Research Governance Office (RGO). Our HREC is certified as a Lead HREC under the National Mutual Acceptance (NMA) scheme, which enables projects to be reviewed and approved across public health organisations throughout Australia and across multiple Australian jurisdictions.
The centralised office for the CAHS HREC and RGO is at Perth Children’s Hospital. The team in this office facilitates the ethical and governance review of proposed projects and monitoring of approved research across CAHS sites.
Research projects at a CAHS site require both HREC and RGO review and approval. Applications can be submitted to both review streams simultaneously.
Do you support sponsored clinical trials?
Yes, CAHS supports commercially sponsored clinical trials and typically has around 180 trials underway at any one time, about 20 per cent of which are sponsored commercially.
How do you recruit your study participants?
Most recruitment is via doctor or specialist referral, with the referrer informing their patient pool about a potential study. Where appropriate, a PI will circulate study information to doctors working in corresponding departments across other Western Australian hospitals.
How much do your trials cost?
There is no fixed cost for running a clinical trial. A range of factors such as study design, study phase, timeline, sample size and whether specialised testing and analysis is needed, will determine the ultimate cost. Refer to our Guide to costs and payments for sponsored clinical trials for a better estimate.
Do you register your trials?
Yes, trial registration involves posting the details of a trial’s design, conduct and administration on a publicly accessible database known as a clinical trials registry. The sponsor (or Principle Investigator for an Investigator initiated trial) must ensure their clinical trial is registered in a publicly accessible database before recruitment of the first participant.
Trial registration is important for participant recruitment because it allows people interested in participating in a clinical trial to search for relevant clinical trials on a single website. Registration also assists health professionals to identify relevant trials for their patients.
Researchers should register trials as early as possible and ensure information such as contact details and trial status is kept up to date. The details of trial registrations are required by our Research Governance Service (RGS).
All CAHS trials are listed prospectively on the Australian and New Zealand Clinical Trials Register (ANZCTR) and Australian Clinical Trials.
Is the data from Australian clinical trials applicable to U.S regulatory submissions?
Yes, clinical trial data from Australia is highly regarded and accepted by international regulatory agencies, including the U.S. Food and Drug Administration (FDA). Australian clinical trials adhere to ICH-GCP guidelines, ensuring the quality and integrity of the data meet global standards.
How do I obtain a CTN (Clinical Trial Notification) acknowledgment?
To obtain a CTN acknowledgment, sponsors submit the necessary trial documentation to the TGA via their online portal. The Australian sponsor is responsible for submitting the CTN, once the trial has ethics approval from a HREC. A clinical trial is deemed to have been notified (and thus may commence) once the CTN form has been submitted with payment of the relevant fee to the TGA. While it is not necessary to wait for it, the TGA Acknowledgment of the CTN is typically received within days of submission.
Does CAHS use standard operating procedures to share with Sponsors?
Yes, CAHS has standard operational procedures for the approval of research. This document provides CAHS employees and other external research colleagues – including students – the requirements for ethics review and approval of research involving human participants within CAHS. This document outlines the responsibilities and functions of the various stakeholders involved in research. It is designed to promote good practice, ensuring that CAHS complies with the Australian Code for the Responsible Conduct of Research, 2018 (‘the Code’) and the National Statement on Ethical Conduct in Human Research 2023 (National Statement).
For the current SOPs please refer to Child and Adolescent Health Service Standard Operational Procedures for the approval of research.
What is the Research Companion service?
CAHS research department has introduced the Research Companion service to facilitate ongoing ethics and governance submissions, as well as post-approval management support.
Sponsors can access this service for a fee. Projects using the service benefit from the direct involvement of Research Companion team members who maintain close contact with sponsors throughout the approval process. Research Companion service ensures competitive ethics and governance approval turnarounds and smoother startups.
For more details about the Research Companion service please refer to (insert link here).
Who should I contact at CAHS to set up a clinical trial?
Please email our clinical trials team and a team member will get in touch to assist you further.
Visit Research across our departments to learn more about CAHS’ research activity.