Clinical Operations Monitoring GCP Audits Australia & New Zealand
AcuTrial Clinical Pty Ltd provides clinical research support to biotech sponsors, contract research organisations and overseas sponsors conducting studies in Australia and New Zealand.
Discuss your study needsFlexible support for sponsors and study teams working across Australia and New Zealand.
Site monitoring across the study lifecycle, with a focus on participant safety, data quality and protocol and GCP compliance.
Hands-on project management and sponsor-facing operational leadership to coordinate study activities and keep delivery priorities clear.
Independent and risk-based clinical site audits to assess study conduct, identify compliance gaps and support effective corrective action.
Local operational support for sponsors establishing clinical studies in Australia and New Zealand.
Sponsor-side operational support to maintain visibility across CRO activities, study progress and emerging delivery risks.
Practical advice and operational support for clinical research teams navigating study set-up, delivery and quality challenges.
More than 10 years of clinical research experience spanning CROs, biotech companies, investigator-initiated trials and independent consulting.
Australian and New Zealand study set-up and operational experience, complemented by Global Lead CRA experience across more than 10 countries and 50–80 sites.
A PhD in Drug Discovery and a pharmacy qualification provide a strong foundation for understanding investigational therapies and clinical research requirements.
Experience in monitoring, independent site audits, audit readiness and CAPA follow-up, supported by ICH E6(R3) GCP certification completed in 2025.
Strong Phase I oncology experience, with additional experience across:
AcuTrial Clinical Pty Ltd supports biotech sponsors, CRO clinical operations teams and overseas sponsors with clinical research activities in Australia and New Zealand.
Our experience connects site-level monitoring with broader project delivery and sponsor-facing operational oversight. We help study teams coordinate activities, address operational issues and maintain attention to study quality throughout delivery.
Whether you need monitoring support, clinical project management, an independent GCP site audit or assistance establishing a study in Australia or New Zealand, contact AcuTrial Clinical to discuss your requirements.