This introductory session examines how Australia fits within an international clinical development strategy, including its streamlined start-up pathway, capabilities across preclinical, early- and later-phase trials, capabilities across variety of devices and therapeutic modalities and the standard for generating clinical and bioanalytical data compliant and acceptable for use in major international regulatory submissions.
Participants will hear directly from Global Victoria and Nucleus Network as well as from an overseas sponsor about their experience conducting a study in Australia – including what worked, the challenges they encountered and what companies should consider before committing – alongside perspectives from clinical, regulatory and laboratory partners.
Key messages
Australia’s value extends beyond speed: quality, efficient start-up, experienced teams and reliable execution are central to sponsor decisions.
The supporting ecosystem matters, including clinical units, CROs, experienced clinical research associates, bioanalytical laboratories and local laboratory services.
Strong ethics oversight should be highlighted to counter any perception that faster start-up means less scrutiny.
Data quality and its contribution to a global development strategy belong in the first webinar.
The program should demonstrate Australia’s broader capability, while using Monica’s phase I experience as a practical example.
The second webinar can examine operational hurdles, solutions and detailed experience working with Australian trial partners
