by Andrew Turner | Dec 20, 2021 | Good Clinical Practice
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...
by Andrew Turner | Oct 11, 2021 | Clinical Trials, Good Clinical Practice
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...
by Andrew Turner | Oct 11, 2021 | Clinical Trials, Good Clinical Practice
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)...
by Andrew Turner | Jun 19, 2020 | Clinical Trials, Good Clinical Practice
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...
by Andrew Turner | Mar 13, 2019 | Clinical Trials, Good Clinical Practice
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...
by Andrew Turner | Jun 30, 2017 | Good Clinical Practice
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...
