Conducting clinical trials in Australia – What every sponsor should know

Conducting clinical trials in Australia – What every sponsor should know

Australia has become a leading destination for early-phase and investigator-led clinical trials — thanks to its strong regulatory framework, skilled researchers, and efficient ethics approval processes. However, to conduct a clinical trial successfully, sponsors must understand their responsibilities, key stakeholders, and the pathways available through the Therapeutic Goods Administration (TGA). 1. Setting the Foundation for … Read more

How to develop an Investigator’s Brochure

Investigator’s Brochure (IB) is one of the critical documents included in the HREC submission package to support the conduct of a clinical trial. As the name suggests, its purpose is to provide investigators with the basic and most up-to-date scientific information on the Investigational Product (IP), including the type and severity of potential adverse reactions … Read more