Are You Looking To Run Your Clinical Trial In Australia & New Zealand?
Mobius Medical is an ISO 9001:2008 certified Australian owned CRO established in 2008 with a proven track record providing outstanding clinical trial management and electronic data capture (EDC) services throughout Australia and NZ
We provide all clients, from the small research centres to large, pharmaceutical and medical device companies, an affordable Electronic Data Capture (EDC) solution.
All our data solutions comply with GCP, FDA and EMEA requirements.
Smart, Agile, Experienced
We are dedicated to assisting young, start-up companies with the development of their products with a single, unified vision: the faster the clinical development stage is accomplished, the quicker novel treatments reach those who need them – the patients.
We look forward to working with you and assure you that, above all, our goal is to compliantly speed up the process of your goal – seeing your new product in the hands of healthcare professionals and patients.
Full Service Contract Research Organisation
Mobius can provide all the services required to take your product from first in man to regulatory approval and beyond including trial design, statistics, site selection, human research ethics committee (HREC) submissions, regulatory compliance, monitoring and reporting.
We can also offer a customised, hosted EDC and data management services.
All of these services or partial services can be provided as required to meet your needs.
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.
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 a clinical trial, deferring responsibility to the HREC (IRB) resulting in faster study start-up.
Your Legal Obligations Are 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 disclosure and source competitive clinical trial insurance policies.
What Our Clients Say
“I have found their expert knowledge and experience of the TGA and FDA regulations and environments, as well as Good Clinical Practice requirements to be invaluable
I have no reservations in recommending Mobius Medical for any CRO related activities.”
Laurie Hook, VP, Clinical & Regulatory Affairs
Relievant Medsystems, Inc.
“Mobius allowed us to achieve our study enrollment and data collection milestones on time, in a high quality manner, and within budget.
I have recommended Mobius to my CEO colleagues and would work with the Mobius team again on future clinical trials in Australia and New Zealand.”
Beverly Huss, MS, President and CEO
Our Experience Is Yours
Offering a highly personalised approach, we work closely with you to accomplish the most expeditious initiation of your trials.
With vast experience of the regulatory environment and ethics committee requirements in the ANZ region, and partnering the very best research centres and key investigators in the region, Mobius can ensure your trials start quickly, meaning data is generated faster, resulting in your product reaching the market sooner.
Mobius has formed alliances with leading experts in their field to ensure all aspects of development are covered.
We have relationships with one of Australia’s leading biostatisticians, direct partnerships with medical device regulatory and health economics experts, and physicians to advise, review and execute clinical evidence reports.
We can assist you at any stage of your product’s development.
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!