Clinical Trials Unit

Simple processes, better trials, improved healthcare

How can we help you?

Clinical trials are an essential tool to answer new questions and test old assumptions in healthcare, but trials can be complex projects and also require specific skills, language, practice and knowledge – it is clinical trial coordinators that provide this expertise.

Our mission is to assist as requested, to help you deliver focussed and streamlined clinical trials to improve patient outcomes, patient experience and healthcare.

Doing things differently… clinical trial coordination as a service

With HMRI’s focus on the translation of health research into practice, we established the HMRI Clinical Trials Unit to provide clinical trial coordination as a service.

Our aim is that you experience:

Easier participation in clinical trials as an investigator
Seamless navigation of ethics and site governance processes
Robust recruitment and data collection
A smooth journey through your clinical trial

Whether you are creating a new clinical trial, you are a clinician planning to open your first clinical trial, or you need assistance to supplement your existing clinical trial portfolio, our goal is to facilitate and enable you by offering:

Clinical trial consulting and advisory services
Access to experienced, ICH GCP certified clinical trials professionals
Quality systems and standard processes
Compliance with National, State and local legislation, regulations and guidelines

Our Services

We aim to support you as needed, whether throughout the whole journey or work with you to identify the areas we can assist you with.

Ethics and Governance Process Management

Provide your existing study documents to our experienced team who will handle all the administrative aspects of your application for ethical and scientific review by a Human Research Ethics Committee (HREC) and/or authorisation of your Site Specific Assessment (SSA) by the Research Governance Office (RGO) at your institution. With experience in REGIS and in navigating the various ethics and governance systems used in other Australian jurisdictions we can:

Review documents prior to submission for issues that commonly result in delays to approval or authorisation
Advise on the selection of the appropriate HREC to review your multi-site or early-phase study
Assist with preparation of the HREA and any relevant additional state modules and privacy statements required up-front to eliminate the need for multiple rounds of review
Prepare site-specific versions of patient-facing documents
Track milestones, assist with timely progress reporting, manage protocol amendments

Central Coordination of Multi-site Clinical Trials

We can support the development and implementation of quality-driven processes for clinical trial conduct from pre-activation to archiving.

Master/Central File set-up and maintenance for your clinical trial
Development of trial-specific Standard Operating Procedures and Manuals
Assistance with data management
Coordination of site training, collection of essential documents, activation and ongoing site communication

Services within your Current Trial or for your existing Trials Team

We can collaborate with you to provide bespoke services to suit your needs for a specific clinical trial or to support your existing trials workforce. Examples of our services include:

Clinical trial budget development and/or negotiation
Clinical trial coordination at site, including remote coordination activities
Support and advice for the implementation of a Quality Management System, including SOPs and Working Instructions

Clinical Trial Consulting

The clinical trial environment in Australia is growing and changing at a rapid pace. Our team is engaged with leading legislative, regulatory and industry organisations and can provide up-to-date information, resources and advice to ensure your clinical trial or program of trials is conducted in line with current best practice.

Do you need help with something we haven’t listed here?

The HMRI CTU may be able to assist. Contact us at HMRIClinicalTrials@hmri.org.au or by using the form below.

Clinical Trial Protocol Development

We welcome contact by researchers in the early stages of protocol development for assistance with:

Preparing a protocol synopsis and comprehensive schedule of assessments
Budget development and grant application preparation
Adherence to relevant legislation, regulations and guidance
Participant information and consent development

Did you know?

The HMRI CTU hosts the NSW Regional Health Partners (RHP) Clinical Trials Community of Practice. Bringing together clinical trial staff engaged in the delivery of clinical trials at each of the member organisations of the NSW RHP, the Community of Practice aims to support participants to:

Strengthen relationships within the clinical trials community across the region
Explore solutions to common problems and learn from each other to encourage the adoption of best practice in the conduct of clinical trials
Increase expertise, quality and efficiency in all aspects of clinical trial conduct
Acknowledge, promote and share achievements