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 results of an RCT are only as good as the design of the trial itself, with inadequately designed studies resulting in unreliable results. A systematic review of 1,147 RCTs examining the consequences of poor reporting ..read more

EMVision Medical Devices reports encouraging progress in stroke-related brain scan trial The post EMVision Medical Devices reports encouraging progress in stroke-related brain scan trial appeared first on Contract Research Organisation CRO Australia ..read more

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 revitalizing the clinical trials agenda and looking for further ways of improving the clinical trials process here in Australia. COAG Health Council has since tasked the now Clinical Trials Project Reference Group (CTPRG ..read more

Services are often outsourced to third party vendors for certain clinical trial activities, particularly where a clinical trial activity must be standardised. Such vendor services can include a centralised review of imaging data, central pathology or laboratory analysis and Investigational Product logistics. Following the decision to outsource a service to a third-party vendor for a clinical trial, different vendors are identified and assessed by a documented audit. Sometimes, sponsors or CROs may have worked with vendors before and already have relationships in place, or recommendations to of ..read more

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, Efemoral I – the use of a novel, balloon-expandable, resorbable, drug-eluting device for the treatment of symptomatic peripheral arterial occlusive disease from stenosis or occlusion of the femoropopliteal or external iliac artery. Read more here. The post Mobius Medical News: Efemoral I P ..read more

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 continues to support Saluda Medical in Australia with ongoing trials in the post market space. We’re absolutely thrilled by the news on 8 March 2022 of full approval from the United States Food and Drug Admi ..read more

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 either of the current commercial sperm separation techniques, Density Gradient Centrifugation (DGC) and Swim-up, which are used to prepare sperm for Intracytoplasmic Sperm Injection (ICSI), a common In ..read more

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 management, team liaison with research teams, ethics committees all under intense compliance to strict regulations. Much of a clinical research associate’s life is spent traveling, visiting clinical trial sites, some ..read more

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 and that the trial is being conducted according to the protocol, Good Clinical Practice, and applicable regulatory requirements.   Historically, moni ..read more

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 with evaluating the conduct of a trial, its management and upkeep are crucial.  Paper-based TMFs came first and are still used by many organizations to this day, where paper documents are filed in mul ..read more