Our collaboration with A/Prof. Andrew Holden and the team at Auckland Vascular Research in New Zealand spans over a decade and we are always proud to be the CRO working on exciting clinical trials with them. Hot off the press in Vascular Specialist last month, is an article on one of our ongoing FIH studies, […]
One of Mobius Medical’s proudest collaborations is with Saluda Medical, a global medical device company focused on patient outcomes, science, and engineering to transform the neuromodulation industry through patented Evoke Closed-Loop Chronic Pain Therapy technology based on the evoked compound action potential (ECAP). Australian CRO for their CE Mark study “Avalon” in 2015 to 2019, […]
Mobius Medical is delighted to be the appointed Contract Research Organisation (CRO) conducting the clinical trial of the Memphasys FelixTM System. Memphasys Limited is an award-winning biotechnology company specializing in bio-separations and reproductive biotechnology for commercial applications. The aim of this clinical trial will be to statistically prove the Felix™ System is not inferior to […]
CROs are now commonplace, as Pharmaceutical and MedTech companies outsource most, if not all of their clinical trial management projects, appreciating the CRO’s contribution to the success of product development. Many CRO employees are former nurses, lab technicians, and new life science graduates. Their daily tasks include clinical trial set up, monitoring, data handling, project […]
What are monitoring and centralised monitoring and how do they differ from remote monitoring? Monitoring of a clinical trial is an essential requirement of GCP and ISO 14155 and is the responsibility of the trial sponsor. The purpose of monitoring is to verify that the rights and well-being of trial participants are protected, to confirm that trial data are accurate, complete, and verifiable […]
What is a Trial Master File? During a clinical trial, a multitude of essential documents are collected to manage the study and verify whether the trial has been conducted in line with the applicable regulatory requirements and Good Clinical Practice (GCP) standards. This collection of documents makes up the Trial Master File (TMF). Since a TMF assists […]
Randomised controlled trials (RCTs) are considered the gold standard for studying the safety and efficacy of new interventions and are generally required by regulatory bodies for approval of new therapies. RCTs reduce bias by controlling both known and unknown confounding factors through random assignment of participants to the intervention under investigation or the control. The […]
EMVision Medical Devices reports encouraging progress in stroke-related brain scan trial
Australia is already an attractive location to host clinical trials with an efficient ethics and regulatory framework, diverse participant recruitment pool and high-quality research facilities just a few of the drawcards. Clinical trials contribute over $1.1bn annually to the Australian economy; so, it is no wonder the council of Australian Governments (COAG) Health Council is […]