What types of oncology trials does your unit support?
We support a wide range of Phase I oncology clinical trials across solid tumours and haematological malignancies. Our capabilities include early-phase, first-in-human, and investigator-initiated studies.
Do you have experience with early-phase or first-in-human trials?
Yes, our team has extensive experience in early-phase oncology trials, including first-in-human studies. We have established protocols and infrastructure to ensure safety, compliance, and timely data collection.
What are your ethics and governance timelines?
We work with Bellberry HREC and strive to meet streamlined start-up timelines. Our team can assist with submissions and provide expected timeframes upon feasibility assessment.
Do you accept feasibility requests from international sponsors or CROs?
Yes. We welcome feasibility requests from both local and international sponsors or CROs. Please contact us or submit a feasibility request form to begin the process.
What patient populations do you commonly recruit?
We recruit patients with a broad range of cancer types, including common and rare cancers. Our referral networks and multidisciplinary care model support diverse and timely patient recruitment.
What are your data management and quality assurance processes?
We adhere to ICH-GCP guidelines and have robust quality assurance procedures in place. All trials are conducted with strict compliance, regular audits, and comprehensive data management systems.
Do you offer dedicated trial staff?
Yes, our unit includes dedicated clinical trial coordinators, research nurses, research assistants, and a principal and sub-investigator for each study. This ensures consistent oversight and communication throughout the trial lifecycle.
How do I initiate a new study at your site?
Please complete our sponsor enquiry form or email our clinical trials team with your study protocol and feasibility questionnaire. We will respond promptly to begin the assessment process.
Can your site conduct complex trials involving genetically modified organisms (GMOs) or viral vectors?
Yes. Our clinical trials unit is equipped to conduct complex oncology studies involving genetically modified organisms (GMOs), viral vectors, and oncolytic viruses. We have access to PC2-certified facilities and work in compliance with the Gene Technology Act 2000 and OGTR (Office of the Gene Technology Regulator) guidelines. Our experienced team operates within established biosafety protocols to ensure safe and compliant handling of these investigational agents.
How quickly can you start up a new clinical trial?
We pride ourselves on an efficient startup process, with the goal to initiate new trials within 4-10 weeks from site selection. Our experienced team works closely with sponsors and CRO’s to streamline approvals and site readiness.
What factors impact study start-up timelines at your site?
Study start-up timelines may be extended if there are delays in receiving the HREC submission package, in responses to HREC queries for lead site applications, or during budget and contract negotiations with the sponsor or CRO. In the absence of such delays, a four-week start-up timeline is achievable at our site.
Can’t find what you’re looking for?
If your question isn’t answered here, please fill out our enquiry form, and a member of our team will be in touch to help you directly.