Much like the Coding Review screen, the Medical Review screen is functionality in Oracle’s Argus Safety that displays the relevant case in a single central window and allows a medical reviewer to see all of the key data points that he or she would use when assessing the case.
From the Medical Review screen, you can see the narrative in the case, case comments, specific company comments, and the individual event-level assessments.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
It’s important to note that this is not just a review window – you can also make modifications to the information on this screen as the medical reviewer.
One of the beautiful things about the Temporal View tab is that you are able to clearly see all of the concomitant therapies, medical history, laboratory dates, suspect medications, and event dates. You can also see a small histogram showing the date and duration of the event and suspect product. This allows you to confirm whether the event was indeed treatment-emergent.
If you checked with a number of your medical reviewers, you may find that they are doing something similar to this on paper when you give them the MedWatch to review, in an attempt to figure out if an event was treatment-emergent. All of this can be done right within Argus Safety.
Additionally, from the Medical Review screen, you can catch and view source files, as well as run any of the many individual case safety reports (ICSR) that come with the system. You can run all of these in draft mode, as it facilitates the ability for some of your medical reviewers, who prefer paper, to still open up a MedWatch report and perform the medical review right there.
In the next post, we’ll highlight how the Argus Safety pharmacovigilance system relates to regulatory report tracking. To read past posts in our Argus Safety features series, click here.