Getting Started

When it comes to clinical trials – time is money

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.

Our Team

We have a team specially dedicated to starting your study

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:

  • Feasibility
  • Site selection 
  • Site contracts
  • Ethics and Regulatory

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

Accelerated ethics and regulatory timeframes

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.

How We Deliver

We Are Experts

Your Go-To Region

Creative Solutions

Rapid Start Up

Australia & New Zealand Provide You with One of the Fastest Regulatory Approval Environments

Pre-study Feasibility

Call us to discuss your next study and how our regional expertise can ensure your trial is a success.

At no cost, we can prepare a draft proposal, outlining possible sites, estimated costs and do-ability in this region.