How CROs Can Keep Engaged Employees and Cut Down Staff Turnover
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 […]
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 […]
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 […]
Benefits of Risk Based Monitoring
What is Risk Based Monitoring? Risk based monitoring is a new monitoring model that has been accepted by the European Medicines Agency and the Food and Drug Administration. It is an innovative risk based approach that focuses on critical study parameters and relies on a combination of monitoring and analytics to oversee patient safety and […]
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 […]
Human Research Ethics Application Replaces NEAF
For many years, Australia has been the one of the most attractive countries to perform clinical investigations for medical devices, pharmaceuticals and in-vitro diagnostics. The Clinical Notification Scheme (CTN) is a straight-forward and fast approval process from the Australian government regulatory organisation, Therapeutic Goods Administration (TGA). As part of the requirement of CTN, and before […]
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 […]
Improving Australia’s clinical trials landscape
The Australian government (NHMRC, the Department of Health and the Department of Industry, Innovation and Science) are constantly working to improve the clinical trial environment in Australia. Some of the initiatives, which have made significant progress in the last year, are: Timely and more efficient research governance authorisation Efficient Ethics Approval Increased Site Readiness and […]