Online regulatory notification of clinical trials

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 year, times to site initiation improved further, with the online clinical trial notification (CTN) scheme. Since July 1, 2015, study sponsors have been notifying the […]

A potential breakthrough in pain relief, right here on Aussie soil…

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 relief of back pain. Watch the recent news article here and read more in this Sydney Morning Herald article.

Clinical Trials Down Under – skipping regulatory approvals!

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 clinical trials quickly. With a streamlined national ethics committee application system in both countries, sites are initiated on average within 4-6 weeks submission. High quality […]

(Don’t) Be Still My Beating Heart..

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 used while the valves are repaired. In this ground-breaking operation, doctors implanted artificial valves inside the patient while their hearts continued to beat. Each patient […]

The Asia-Pacific Summit for Medical Devices

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 on medical device regulations in the Asia-Pacific featuring top experts from Taipei, Singapore, Jakarta, Sydney, Kuala Lumpur, and Beijing right to you in beautiful San […]

A Snippet of Clinical Trial History

James Lind is considered the first physician to have conducted a controlled clinical trial of the modern era. Dr Lind, whilst working as a surgeon on a ship, was appalled by the high mortality of scurvy amongst the sailors. He planned a comparative trial of the most promising cure for scurvy. His vivid description of […]

Cash back for Research & Development in Australia

Many international researchers are choosing to conduct their research and development in Australia to take advantage of the new R & D tax incentive program. The key concepts are: A 45% tax offset for expenditure on eligible R & D activities which may be refundable to companies with a group wide turnover of under $20 […]

Safeguarding Patient Privacy & Safety in Clinical Trials

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 Drug Administration (FDA) has raised the standard for what constitutes satisfactory pharmacovigilance. Drug safety has consequently become an ongoing process which begins earlier and ends […]

Global Accessibility of Clinical Trial Data

Clinical trials are increasingly being conducted on a global scale, with the potential for variability of workflow processes. A web based electronic data catpure (EDC) system is critical to effectively work cross-organizationally, over a large geography. Most importantly, because the solution is web-enabled, information is easily accessible from anywhere, at any time.