What is Risk Based Monitoring? Risk based monitoring is a new monitoring model that has been accepted by the European Medicines Agency and the Food and Drug Administration. It is an innovative risk based approach that focuses on critical study parameters and relies on a combination of monitoring and analytics to oversee patient safety and […]
Mobius Medical, like many other CROs all over the world, is privileged to be involved in the development of a myriad of novel innovations, and life changing medical devices, diagnostic tools and medicines. We are in the business of providing clinical trials management, strategic advice and digital solutions to the inventors and manufacturers of these […]
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 […]
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
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 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 […]
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 […]
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.
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 […]