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 […]
Registry data speaks volumes for Australia and New Zealand
Australia and New Zealand have each registered more clinical trials (per capita) than Germany, UK and the USA according to the World Health Organisation International Clinical Trials Registry Platform! The graph represents the proportion of trials per capita. Ref. Link to data
Why conduct your next trial in Australia
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 partner to many varied clients who return to us time and time again to initiate and complete another successful trial. We hope they also enjoy […]
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 […]
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.
Validation of eClinical Systems
When validating any eClinical system (used to collect data submitted to the FDA) regulations regarding electronic records and electronic signatures (FDA 21 CFR Part 11) require documented evidence that the eClinical system does what it was intended to do and that it does so accurately and consistently. In Australia the ICH-GCP guidelines are similar in […]