The longer it takes to start your clinical trial or study, the longer before you can go to market.
We get this. Building on the advantages of Australia and New Zealand’s ethics and regulatory timeframes, we have developed a dedicated in-house start-up team. Along with our hugely efficient processes, we can achieve your ethics and regulatory approval and first site initiation visit in 35 days.
Having started hundreds of clinical trails and studies, our start-up team works with you from your first meeting with us through to site initiation and ongoing reporting. This includes:
We make sure your study is set up for success, and all the boxes are ticked, so that it gets approved quickly.
Australia and New Zealand
Australia and New Zealand provide you with one of the fastest regulatory approval environments in the world.
In New Zealand, only one ethics submission is required. Our regulatory authority averages 14 days [source: Medsafe], compared to three months in the US.
A US Pre-Investigational New Drug (IND) submission is not necessary to initiate first-inhuman clinical trials in Australia or New Zealand.
This means that you can initiate a clinical trial in parallel to the preparation of a US IND submission, often commencing dosing within a single review cycle of 6-8 weeks.