Why Australia?

Regulatory environment

Australia’s regulatory environment uses the clinical Trial Notification (CTN) process, allowing rapid approval by local HREC/ IRB of clinical research sites to conduct early phase clinical trials. The process doesn’t require IND submission prior to commencing the trial, even for First Time in Human or proof of concept studies.

Clinical quality – ICH GCP

At Nucleus Network, all clinical research is conducted in accordance with ICH GCP Guidelines, with all clinical data generated acceptable to the US FDA and European EMEA standards.

Investigational Product
  • Phase I manufacture is exempt from requirement to manufacture in a cGMP licensed facility • Australia follows same principles as 2009 US Guidance on manufacture for Phase I clinical trials
  • There is no requirement for a QP person (unlike Europe)
  • Large number of sponsors elect to compound finished product ‘just in time’ at our site
  • Often utilise the preclinical formulation
  • NN does also have access to a cGMP TGA licensed facility