We support trial sites across Hunter New England with feasibility and study start-up, simplifying engagement and streamlining processes to enable efficient, high-quality trials and faster study start-up for sponsors and Clinical Research Organisations (CROs).
A single front door. Faster start up
For commercial sponsors and CROs, the CTSU acts as a single “front door” to the Hunter New England clinical trials ecosystem, simplifying engagement and supporting confident site selection and trial delivery.
The CTSU provides:
This coordinated model improves responsiveness, reduces start‑up delays, and provides sponsors with confidence that trials can be delivered reliably and consistently across the region.
Sponsors may engage either directly with Principal Investigators or through the CTSU for initial trial interest and feasibility. Engagement via the CTSU is preferred where sponsors are seeking coordinated responses and faster turnaround during the feasibility and site selection process.
The CTSU provides practical, hands‑on operational support for experienced and emerging Principal Investigators and study teams delivering commercial clinical trials across Hunter New England Health. We work with suitably qualified individuals at all stages of their trial leadership journey, supporting both established PIs and those seeking to step into PI roles for commercial studies.
Our centralised support model is designed to reduce administrative and operational complexity, strengthen governance and compliance, and support consistent trial delivery. We partner closely with study teams to provide guidance, coordination, and operational expertise from feasibility through to site activation and readiness for patient recruitment, enabling trial teams to focus on participant identification and enrolment.
The CTSU supports commercial trial teams by:
Helping identify suitable clinical trial opportunities and assessing whether sites have the patients, infrastructure, and capability needed to successfully deliver the study.
Managing the approvals process required to ensure clinical trials meet all ethical, governance, and regulatory requirements before commencing.
Supporting study teams to navigate trial budgets, agreements, sponsor expectations, and key start-up activities to enable efficient trial activation.
Overseeing trial logistics, timelines, and resource coordination to support smooth and efficient study delivery across all stages of the trial.
Promoting safe, compliant, and high-quality clinical trial delivery through established procedures, governance oversight, and quality management systems.
Supporting both new and experienced Principal Investigators with the knowledge, guidance, and operational support needed to confidently lead and deliver commercial clinical trials.
As an additional service, the CTSU can provide experienced clinical trials coordinators to support trial delivery, including participant screening and recruitment, where appropriate and negotiated as part of study delivery arrangements.
