New GCP addendum E6 R2

Since the GCP (E6 R1) was first released in 1996, clinical trials have evolved substantially in complexity, technological capabilities, and costs. ICH E6(R1) has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and reliability of trial […]

Mobius Opens Melbourne Office

We are excited to announce the opening of our new office in Melbourne Melbourne is globally recognised as a leading Biotech innovation hub and Mobius has several large projects running at many research centres there. Mobius Medical Pty Ltd | Melbourne Level 4, 99 Commercial Road Melbourne VIC 3004 Australia Tel +61 3 8595 0970

Human Research Ethics Application Replaces NEAF

For many years, Australia has been the one of the most attractive countries to perform clinical investigations for medical devices, pharmaceuticals and in-vitro diagnostics. The Clinical Notification Scheme (CTN) is a straight-forward and fast approval process from the Australian government regulatory organisation, Therapeutic Goods Administration (TGA). As part of the requirement of CTN, and before […]

Mobius Medical is ISO:9001 certified!

Mobius Medical is pleased to announce that BSI has granted ISO:9001 certification for our Quality Management System. We’re proud of our QMS having worked on it over several years to ensure that it’s robust, compliant and nimble. Our existing clients already have confidence in the Mobius QMS, and our smaller clients wholly rely on it […]

Meet Mobius at AdvaMed 2016

Attending AdvaMed in Minneapolis this year are the two founding members and Principals of the SME’s favoured boutique CRO in Australia and New Zealand Stefan Czyniewski and Suzanne Williams will be in San Francisco on 12-14 October and are keen to visit you, if you’re interested in learning more about the advantages of running your clinical […]

Mobius is hiring

  We’re looking for amazing people skills, confidence and ability to get along with the trickiest of site staff, and a happy, can-do attitude is essential. Technical skills, GCP practical knowledge, and attention to detail are a given and evident through your track record. You will have previously worked as a Clinical Monitor, CRA and/or […]

Great news story from our client Tendyne

Gympie Grandma Blanche says she owes her life to Professor Darren Walters and his dedicated cardiac team. 9 News uncovers why The Prince Charles Hospital is leading the world in heart treatment and how a new device could save thousands of Australians.

Gaining access to an investigational product after patients have completed a clinical trial – Australia

Principal investigators are often asked by their patients if they can still access the investigational product (IP) after they have completed the clinical trial. In some medical device trials, using an implantable product for example, typically the product is provided to the participant during the trial, and not required to be returned. In pharmaceutical and […]

When Pain Persists

Back pain – almost all of us has either had it or will experience it in our life time. In fact, four million Australians may be suffering from low back pain right now, and for around 40% of people that pain will persist and become chronic with devastating effects. But what if you could end […]