Acting as a central coordination partner, we support investigators, collaborative research groups, sponsors, and study teams to plan, implement, and manage clinical studies across a range of settings and funding models.
Our team delivers structured project oversight, strong governance, and practical operational expertise to support the successful delivery of single‑site and multi‑centre trials. We work closely with study teams throughout the trial lifecycle to support protocol implementation, regulatory compliance, risk management, and consistent study conduct across participating sites.
Supporting the preparation, submission and ongoing management of ethics, governance and regulatory requirements throughout the life of the study.
Coordinating trial operations, timelines and communication to support efficient and consistent study delivery.
Proactively identifying operational risks and supporting timely resolution of issues to minimise delays and maintain compliance.
Ensuring studies are conducted in line with Good Clinical Practice (GCP), regulatory requirements and organisational quality standards.
Supporting sites through start-up, initiation and day-to-day trial activities to help maintain study readiness and performance.
Facilitating monitoring activities and tracking site and study performance to support high-quality trial conduct.
Supporting accurate data management, reporting processes and governance requirements throughout the study lifecycle.
Managing end-of-study activities including reconciliation, documentation finalisation and compliant archiving processes.
As part of the Hunter New England Clinical Trials Coordinating Centre, these specialist capabilities are embedded within a coordinated model to support end-to-end clinical trial delivery. These include:
