Electronic Trial Master Files (eTMFs): Worth Trialling to Master Filing?
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 […]
Remote and Centralised Monitoring -Monitoring Challenges During Lockdown
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 […]
Accurate Reporting of Randomised Clinical Trials
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
EMVision Medical Devices reports encouraging progress in stroke-related brain scan trial
COAG Health Council Revitalized Clinical Trials Agenda
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 […]
Outsourcing Vendors for Clinical Trials
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 […]
AusTrade Clinical Trials Capability Report
AusTrade’s latest Clinical Trials Capability Report has some interesting facts n figures Between 2012 and 2015, phase I activity has grown by 17.2% in Australia, compared to 1.8% globally Between 2012 and 2015, phase I activity has grown by 17.2% in Australia, compared to 1.8% globally In early phase clinical trials, Australia is 28% cheaper […]
Congratulations to AbilityMate – 2017 National Disability Excellence in Innovation Award Winner
11We are please to report that AbilityMate has won the 2017 National Disability Excellence in Innovation Award “We’re living in an era of design where human invention, empowered by technology could reshape the lives of people with disabilities for the better.” Melissa Fuller, co-founder AbilityMate AbilityMate is a social enterprise that combines the power of
Magic Shoes – our exciting collaboration with Ability Mate
Mobius Medical, like many other CROs all over the world, is privileged to be involved in the development of a myriad of novel innovations, and life changing medical devices, diagnostic tools and medicines. We are in the business of providing clinical trials management, strategic advice and digital solutions to the inventors and manufacturers of these […]
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 […]