Our quality management framework is built to meet international Good Clinical Practice standards and Australian regulatory requirements. Every site in our network operates under the same documentation and training requirements.
All clinical operations and documentation standards align with ICH-GCP E6 R2. This is the foundation of our training, SOP library, and essential document requirements.
We operate under the TGA Clinical Trial Notification (CTN) scheme. All trials are notified to the TGA prior to activation. Site-specific regulatory documents are prepared and maintained to meet TGA requirements.
We use the NHMRC Single Ethical Review (SER) framework, which allows one HREC to cover all sites in the network. This reduces approval timelines without compromising ethical oversight.
A formal library of standard operating procedures governs all aspects of site conduct, from patient consent through to adverse event reporting, data management, and investigational product handling.
All site staff involved in trial conduct must hold current GCP certification. Training is provided at no cost to sites, and training records are maintained centrally with automated renewal reminders.
All data handling, storage, and transfer practices comply with the Australian Privacy Act 1988 and relevant health records legislation. Data governance is documented at the protocol level.
When a sponsor monitor or QA auditor visits one of our sites, they will find:
We use practical clinical technology tools to reduce manual documentation burden and improve data quality across the network.
We work with sponsor-nominated EDC platforms and can support a range of common systems. Our site coordinators are trained in data entry standards and query resolution.
Electronic consent is available for protocols where it is appropriate and sponsor-approved. All eConsent processes are validated against HREC requirements and ICH-GCP principles.
Essential trial documents are stored and version-controlled in a central system. Sites access only the documents relevant to their activation. Archiving at closeout follows ICH-GCP requirements.
We can provide a detailed quality briefing for sponsor QA teams during the feasibility phase.