Trials Without Borders: Regulatory & Site Landscapes
Source: Clinical Leader
Experts Megan Robertson and Tina Soulis, Ph.D. discuss the regulatory and ethical landscape for conducting clinical trials in Australia. Topics covered include everything from CTA/IND submission processes and EC/IRB review timelines to ICH E6(R3) alignment and decentralized trial requirements. They also delve into the Australian site landscape, including public vs. private site performance, contracting bottlenecks, investigator engagement, and key operational considerations for U.S. biotech sponsors planning local trial execution.