When you connect with an agency of a pharma company for medical monitoring review in Australia, you are actually seeking medical expertise for clinical trials. Let us walk you through what medical monitoring is and how it is an important component of the clinical research process.
Medical monitoring review in Australia offers medical expertise and oversight for the entire clinical trial. Such reviews are quite helpful from the initial study design through final study close-out. They also ensure the clinical integrity of the trial subjects and offer safety accountability through the duration of the study. It also offers expert points of reference for both investigative sites and study team members.
One point to understand here is that a clinical research associate (CRA) who help in investigating sites whether they are adhering to all the clinical protocols and reporting requirements works differently from a medical monitor who offers medical expertise for trial oversight and safety concerns. The field of study for medical monitors are wide and they answer specific questions and protocol issues relating both to subject safety and trial management.
They take note of the following:
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They answer inclusion and exclusion questions from investigative sites, study teams, and CRAs.
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They can also answer specific questions to the protocol during the site start-up process.
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Medical monitors coordinate with other personnel involved in the study to ensure that information is accurate and consistent.
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They address safety issues throughout the study from sites and the study team.
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They have the responsibility of actively interacting with investigative sites.
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They offer guidance to the subject when in need.
That said, medical monitors support the entire clinical trial, from design to close out. When the protocol is being designed, the monitor could be called on to assess the inclusion and exclusion criteria, such as the factors which would qualify a patient for the trial and which would disqualify a patient for the trial.
At the start of the trial, the medical monitor shall conduct an initiation visit. The purpose of this visit is to have a detailed overview of the study procedures and sponsor expectations for a given clinical trial, which includes an assurance that each member involved in the trial is clear about their role.
As the study is underway, the medical monitor will be available for 24*7 to help. Every scenario cannot be accounted in advance and so, the monitor should be present during the study all the time so that nothing is stopping the study to get completed on time.
For more information about medical monitoring review in Australia, reach out to us. We will help you.
