Are You Looking To Run Your Clinical
Trial In The US, Australia or NZ?
Mobius Medical is an ISO 9001 certified boutique CRO established in 2008, providing outstanding clinical trial management and electronic data capture (EDC) services throughout the United States, Australia & New Zealand.
Consider Australia
Choose Mobius Medical
Local Sponsor
Therapeutic Goods Administration (TGA) mandates that an Australian entity sponsors ALL clinical trials.
Mobius acts as local Australian sponsor on behalf of our overseas clients.
This responsibility includes:
- Contractual arrangements for sites
- Indemnity, site payments
- Safety reporting responsibility to TGA
Speed of Start up
Australia’s TGA operates an expeditious on-line notification scheme, following approvals from ethics committee and local institution (or health authority).
Medical device trials are not regulated in New Zealand and only ethics/institutional approval are required.
Pharma studies do require NZ regulatory approval from SCOTT.
Cost Savings
Mobius works diligently to deliver nimble, efficient services that save time and money for our clients. Our EDC, and supplementary options such as ePRO/dairy, IWRS is built in-house saving our clients costs associated with EDC vendors.
Clinical trials conducted in Australia are fully eligible for the Australian R+D tax program which provides cash rebates of up to 43c for each $ spent.
We are hiring
Mobius employs only the most talented, motivated, passionate and conscientious individuals ensuring our service to our clients is simply the best. Our doors are always open to self-starters so drop us a line below if you’re interested in discussing a particular role.
We Manage a Wide Variety of Clinical Trials
for our Partners
Mobius Medical prides itself on quickly learning new therapeutic areas and modes of therapies.
We have experience in most therapeutic areas and across a variety of device, medicine and diagnostic investigational products.
Working in FIH to pivotal, Phase I – IV, we have expertise you can count on.
Click on a body zone for some examples of our current and recent projects.
We Manage a Wide Variety of Clinical Trials
for our Partners
Mobius Medical prides itself on quickly learning new therapeutic areas and modes of therapies.
We have experience in most therapeutic areas and across a variety of device, medicine and diagnostic investigational products.
Working in FIH to pivotal, Phase I – IV, we have expertise you can count on.
Local
Australian
Sponsor
9001
Certified
QMS
Local
Case
Support
What our clients say:
Relievant Medsystems
VP Clinical and Regulatory Affairs
Route 92 Medical, Inc
VP, Clinical Affairs
Mobius staff have been supporting our trial for the past year and a half. They have very capably handled ongoing interactions with the site coordinator(s) to ensure completion of key tasks. During the pandemic Mobius found and secured local NZ CRAs. This was incredible while much of the rest of world had to stop their trials, we were able to keep going.
Saluda Medical
President North America
Cardiac Dimensions
VP Clinical Programs
Mobius Medical is a great example of the new style of CROs – responsive, easy to work with, cost-effective, collaborative and comprehensive in all their service offerings from monitoring to e-solutions for patient recruitment. Cardiac Dimensions could not have chosen a better partner for our investigative sites in Australia and New Zealand.
Expertise in all US, Australian and New Zealand regulatory requirements
Fee Structure
Mobius Medical has a strong ethos that our clients should only pay for work done. All contracts are negotiated on a time-cost basis until our clients are satisfied with the line items required to accomplish the project deliverable, and associated costs. No hidden costs, no surprises and no fixed fees.
Our Experience Is Yours
With vast experience of the regulatory environment in all regions, and partnering the very best research centres and key investigators, Mobius can ensure your trials start quickly. We have built an exemplary reputation for ensuring your trial is a success.
Australian CTN Scheme
A distinct advantage to conducting clinical research in Australia (and New Zealand) is the expeditious CTN (clinical trial notification) scheme. Australia’s TGA requires only a notification of clinical trials, deferring responsibility to the HREC (IRB) resulting in faster study start-up.
Repeat Business
When Mobius receives a request for proposal from a previous or present client, we believe we have achieved success. On our sixth project for one client, and with many more coming back to us for their next phase trials, we are extremely proud to know we are doing a great job!
Legal Obligations Covered
Mobius can assist with all required legal requirements. We act as the local sponsor (for overseas entities), draft clinical trial agreements, indemnity agreements, financial disclosures and source competitive clinical trial insurance policies.
Our Partners
Mobius has formed alliances with leading experts in their field to ensure all aspects of development are covered. We have relationships with leading biostatisticians, direct partnerships with medical device regulatory and health economics experts, and physicians to advise, review and execute clinical evidence reports.