GLOBAL ENTERPRISE PARTNERS

Clinical trials partner in Australia, 
New Zealand and USA

Global sponsors and CROs trust Mobius as their local extension in Australia, New Zealand, and the USA. We deliver results, seamlessly integrated with your global operations.

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Where do you need a partner?

When you're running critical trials at scale, you need a local partner who can execute with speed, effectiveness, and compliance. With ISO 9001 certified processes, we get you there.

01

Local site activation

02

Local regulatory expertise

03

Compliant, secure, high-quality data

04

Seamless ANZ→US bridging

Fast, reliable study start-up

Activate, train, and manage ANZ sites with precision and speed using our trusted investigator network.

"Responsive, tailoring your approach and support to our specific circumstances. You are aware of and work within our budget limitations, providing genuine recommendations on essential services while offering a high quality service."
– Mobius Client

Navigate ANZ compliance with confidence

We manage TGA CTN submissions, ethics approvals, and documentation in full alignment with ICH GCP & ISO 14155.

"Great follow-up, very knowledgeable, friendly, collaborative, and will go above and beyond to help where possible."
– Mobius Client

Deliver inspection-ready results

Our ISO 9001-certified QMS ensures data integrity, security and full GCP compliance across every site.

"Responsive, tailoring your approach and support to our specific circumstances. You are aware of and work within our budget limitations, providing genuine recommendations on essential services while offering a high quality service."
– Mobius Client

Extend trials from ANZ to global markets

Leverage early ANZ data to accelerate FDA and EU submissions through our established cross-region model.

"I was thankful to have such a reliable and responsive CRO managing our trial in Australia since it was not cost effective to go there ourselves. Mobius did everything for which they were contracted on time or ahead of schedule."
– Mobius Client

We integrate seamlessly with your team

Mobius optimises for precision, responsiveness, and MedTech expertise, embedding into your programme as a trusted extension.

Responsive

Founder-led team, immediate decision-making, no layers of bureaucracy

Compliant

ISO 9001-certified QMS, ICH-GCP/ISO 14155-aligned trials, globally accepted data.

Efficient

Bespoke solutions matched to your study’s needs. Nothing more, nothing less.

Hand-over and trust us to deliver

Our capabilities are plug-and-play, so you can use us how you need. We align to your programme plan and own local execution with clear accountability and reporting.

Clinical Trials

End-to-end clinical trial delivery across Australia, New Zealand and the USA. From concept to market approval, we manage feasibility, site activation, patient recruitment and data integrity to ensure compliant, efficient studies aligned with your goals.

Site Activation & Support

Activate, train, and support high-performing clinical sites with seamless coordination and compliance oversight. We manage site logistics, audits, hybrid models, and payments to keep studies running smoothly from initiation to closeout.

Physician Interface

Collaborate with Key Opinion Leaders and experienced investigators to strengthen trial design and execution. We integrate clinical expertise into every stage, from protocol development to ongoing site collaboration and performance.

Regulatory Affairs & Planning

Navigate complex global requirements with confidence. We develop and execute regulatory strategies, manage ethics submissions, act as local sponsor, and coordinate approvals with FDA, TGA, and HREC to keep trials inspection-ready.

Quality & Safety

Maintain continuous oversight with our ISO 9001-certified QMS. We manage GCP audits, medical monitoring, safety reporting, and CAPA systems to ensure every study meets the highest quality and compliance standards.

Data Analysis & Reporting

Deliver trusted data and confident decisions. We handle EDC setup, data validation, biostatistics, and clinical reporting with full regulatory alignment and audit readiness, ensuring reliable outputs for submissions and publications.

Commercialisation & Market Access

Extend value beyond the trial. We support reimbursement strategy, market access planning, post-market surveillance, and go-to-market development—connecting you with partners to bring innovations successfully to patients.
“Think of us as your embedded clinical team.
We simplify complex processes, keep trials inspection-ready, and adapt as your product evolves.”
Suzanne Williams, Co-founder @ Mobius

The Mobius difference

Traditional CROs are rigid and impersonal. Mobius is founder-led, responsive,
and embedded as part of your team.

Traditional CRO

Rigid processes
Highly structured with little room for change
Personalized approach
Projects are tailor-made for
your needs with room to pivot
Just another client
Revolving door of project managers who
don't offer any personalization
Engaged, responsive team
Founders and project managers who embed into your team and champion your goals
Generalised MedTech Knowledge
Expertise may be lacking in
medical device trials.
Deep, niche expertise
Medical device experts from
trial design to data management

More than a CRO. We’re your launchpad.

Our ecosystem of partners extends your reach beyond clinical trials. From pre-clinical testing to market access, Mobius connects every part of your pathway, so nothing is left behind.

What global teams say about us

Our reputation is built on responsiveness, reliability and compliance

CASE STUDY

Revolutionising sperm selection with safer, stress-free technology

A new electrophoretic system offered a faster, safer alternative to conventional sperm selection. In a multicentre pivotal trial, it outperformed Density Gradient Centrifugation, matched Swim-Up, and showed no adverse events—supporting CE Mark submission.

Read case study →
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CASE STUDY

Early feasibility to global pivotal trial for mitral valve innovation

An innovative repositionable mitral valve system underwent early feasibility trials in Australia before scaling to a global pivotal study. Results showed durable valve function, improved survival, and quality of life—culminating in CE Mark (2020) and FDA approval (2025).

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CASE STUDY

Validating a non-invasive pain relief device for pregnancy

Pregnant women in their third trimester experienced better sleep and less pain using a specialised maternity airbed tested in a Mobius-run pilot trial. The study validated safety, comfort, and efficacy—proving a non-invasive way to ease late-pregnancy discomfort.

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"Mobius Medical have been a pleasure to work with. Their staff are reliable, they have solutions for nearly every query and have a range of experience being able to support from conception through to closeout."
“A great example of the new style of CROs – responsive, easy to work with, cost-effective, collaborative and comprehensive in all their service offerings. We could not have chosen a better partner for our investigative sites.”
"The single most crucial attribute that Mobius Medical provides is their personnel. They have staffed an incredibly skilful, competent and reliable team which is second to none. Enabling them to execute exceptionally well as an organization."

How we integrate with global programmes

Straight answers to the questions sponsors and CROs ask before they work with us.

How do you align with our SOPs, TMF and QMS?

We’re ISO 9001-certified and can fully align with your SOPs or integrate our own. Our eTMF, CTMS, and QMS are audit-ready and inspection-compliant, ensuring seamless collaboration with sponsor systems.

Can ANZ feasibility data be used directly in FDA/EMA submissions?

Yes. Australian and New Zealand trials follow ICH-GCP/ISO 14155, accepted by the FDA and EMA. Data generated here routinely supports IDE, PMA, and CE Mark submissions.

What are typical HREC/ethics timelines in Australia & NZ?

Initial ethics approval can be achieved in as little as 6-12 weeks, with site contracts and approvals around 4 weeks. Regulatory notifications (medical devices) is same day. Site start-up is typically faster than in the US or EU given the regulatory notification only pathway for most device studies. Pharma studies in NZ require regulatory approval which can run in parallel to other reviews.

What systems do you use for EDC and data management?

We work with validated systems and our in-house built EDC uses Dacima platforms and hosting. Our in-house data management and biostatistics team ensures compliant setup, real-time data review, and clean, analysis-ready datasets. All EDC and DM staff are Australian-based, ensuring eligibility for Australia R+D tax incentive programs.

How do you ensure safety reporting and inspection readiness?

Our team follows ISO 14155 and ICH GCP requirements with ongoing audit trails, SAE reconciliation, and continuous training. Inspection readiness is embedded from day one—every file, every form, every visit.

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Expand your reach with Mobius

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