Australian CRO and clinical trial services

Start with the research question and intended use of evidence

Study design should address evidence needed for development, registration and commercialisation. We support research strategy and protocol discussions and identify documentation and resource issues to resolve before start-up.

• Clinical research strategy and protocol design support
• Clinical trial site selection, engagement and project communication
• Coordination with hospitals, research teams and stakeholders

Include ethics and regulatory arrangements in start-up preparation

Australian clinical research needs ethics and regulatory pathways assessed against product and study details. CTN/CTA and research ethics review requirements are distinct. Clinical trial Sponsor responsibilities should also be distinguished from product supply Sponsor responsibilities.

• Ethics and applicable regulatory submission support
• Coordination of responsibilities, documents and start-up conditions
• Research site and stakeholder communication

Support execution, data and reporting

Coordinate project management and sites within scope, connecting data management, statistics and clinical reports so execution aligns with evidence objectives.

• Clinical project management and site coordination
• Data management and statistical analysis support
• Connecting clinical reports with registration evidence

Related submission cases

Explore product classes, project considerations and redacted certificates from submissions our team supported.

Frequently asked questions