Mobius Medical is a Contract Research Organization (CRO) providing a turnkey solution, end-to-end service, for the management of clinical trials. Our focus is on medical device clinical trials and specifically Class II, III and active implantable medical devices. Our key focus is designing and implementing a clinical strategy specific to our clients' needs and their investigational product. Mobius conducts clinical trials in the United States, Australia and New Zealand.
Australia has long been a destination for US companies wanting to conduct Early Feasibility Studies (EFS). With an expedited regulatory pathway taking 1-2 days to obtain approval, IRB approvals in 12 weeks, and a very competitive R&D tax incentive, US companies can obtain EFS data quickly to support IDE applications. With offices in Australia and the US, Mobius can seamlessly jump from a single center EFS study in Australia, to multicenter Pivotal studies incorporating sites across the US and Australia. At Mobius we focus on strategically design studies to expedite commercialization.
Why work with us
ANZ-to-USA clinical pathway expertise
We specialise in bridging early feasibility studies in Australia/New Zealand to pivotal trials in the United States—accelerating regulatory pathways and time to market.
End-to-end, MedTech-focused CRO services
From clinical strategy and regulatory planning through to execution, data management, and market access, we deliver a fully integrated, device-focused clinical development solution.
Globally accepted, high-quality data
Our ISO 9001-certified systems and alignment with FDA, TGA, EMA, and ICH-GCP standards ensure data integrity and acceptance by international regulators.
Faster, cost-efficient trial delivery in Australia
Leveraging Australia’s rapid approval timelines, strong investigator networks, and R&D incentives, we help sponsors generate high-quality data quickly and cost-effectively.
Founder-led, agile and collaborative approach
As a boutique CRO, we embed as an extension of your team—offering responsive decision-making, tailored strategies, and deep clinical expertise across the full product lifecycle.
