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… read more →
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… read more →
Mobius Medical spends a great deal of time and business development dollars informing our Northern Hemisphere colleagues of some reasons to come to Australia to conduct trials. We are CRO… read more →
The Australian government (NHMRC, the Department of Health and the Department of Industry, Innovation and Science) are constantly working to improve the clinical trial environment in Australia. Some of the… read more →
The Australian clinical trial regulatory process reduces the time to site initiation, by ONLY requiring ethics committee/clinical site approval, followed by a notification to Therapeutic Goods Administration (TGA). But this… read more →
Mobius Medical is again extremely excited to be partnering homegrown, Australian company, Saluda Medical, in their clinical trial of a spinal implant, which may provide a new breakthrough in the… read more →
One of the most advantageous aspects of conducting clinical trials in Australia & New Zealand is the expeditious regulatory ‘notification-only’ scheme, which enables companies to initiate even first in human… read more →
Using a pioneering procedure, a Sydney surgery team have replaced the valves on two hearts while they were still beating. Traditionally, patients have their hearts stopped and a bypass is… read more →
Mobius Medical is delighted to be a sponsor of the upcoming San Diego Event to Meet Top Device Experts from the Asia-Pacific. The Asia-Pacific Summit is a two-day intensive summit… read more →
Proper management of patient data has become an increasingly sensitive issue with the advent of Good Clinical Practice (GCP), 21 CFR Part 11, and HIPAA. In addition, the Food and… read more →
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