Data regulators accept, worldwide
Remove the biggest question mark before it’s asked.
01
Global standards, as standard
Australian trials run to ICH GCP, the same standard the FDA and EMA expect, and Avion CRO collects data in a CFR Part 11 compliant manner.
02
Routinely accepted
Data from Australian studies is routinely used in FDA, EMA and other global regulatory submissions.
03
Nothing needs repeating
Early-phase data generated in Australia feeds directly into later-phase programmes anywhere in the world, so an Australian start never becomes a detour.
Common Questions
Yes, routinely. Australian trials run to ICH GCP, the same standard the FDA expects, and data from Australian studies is regularly used in FDA, EMA and other global regulatory submissions.
No. Early-phase data generated in Australia to ICH GCP feeds directly into later-phase programmes anywhere in the world.