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The Australian Regulatory Framework is the fastest in the world for undertaking early phase clinical trials.

  • Site Initiation Visit (SIV) and Study Start can be achieved in 5 - 6 Weeks.

 CPR Pharma 2016

Working within this robust and efficient framework expedites the process of running a clinical trial.

  • No IND required for clinical trials
  • Full GMP material is not mandated for Phase I

This means that a Site Initiation Visit (SIV) and Study Start can be achieved in 5 - 6 Weeks and allows Sponsors to gain critical Go/No Go information on their product before allocating resources to these activities.

The Australian regulatory body for clinical trials, the Therapeutic Goods Administration (‘TGA’), offers two schemes for conducting clinical trials in Australia; the CTN Scheme and the CTX Scheme.

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