Rodney Lemery

  The last post we wrote on Argus Safety features was about the system’s autocomplete functionality. Another great feature of Oracle’s safety and pharmacovigilance system is the ability to quickly go back to an adverse event case that you previously accessed. This can be done in just a couple of clicks from the menu, saving you […]

  When evaluating Oracle Argus Safety for the reporting and management of adverse events or product complaints, one thing is clear to me; a company can save a tremendous amount of time by leveraging Argus’ innate functionality to assist in the tedious tasks around case entry. In the next few blog posts, we will look at several […]

  Last week we covered dashboards in Oracle’s Argus Safety. Today we’ll talk about Worklists. Worklists in the drug safety and pharmacovigilance system can be seen as the end-users task list for the day. While there are many Worklists to help organize a company’s users, today we will focus on two of the main ones, which […]

  We recently discussed reporting and the tracking of E2B transmissions in Oracle Argus Safety. Today, we’ll highlight some of the dashboards that are available in the drug safety and pharmacovigilance system. As you can see from the menu in the first screenshot below, these are the dashboards built into the system. 

  In our last post on Argus Safety features, we talked about the tracking of ICSRs. For today’s post, we’ll highlight reporting in Argus Safety. Entering the parameters to run a report is very intuitive because the parameters match all of the dropdown lists that legacy Oracle users are already familiar with. 

  When it comes to periodic reporting, we feel that the generation and tracking of periodic reports in Oracle’s Argus Safety is far easier than in other safety and pharmacovigilance systems. In the system, periodic reports are all created and generated from a central screen within the application.   The four basic kinds of periodic […]

  In Argus Safety, all of the parameters for configuring the worldwide regulatory reporting rules are clearly identified on a single administration screen. You have the capability of selecting various case or event-level attributes, as well as using very advanced conditions, to focus the automated triggering of these report rules in various circumstances. 

  One of the things we hear most is how simple Oracle Argus Safety is to navigate. In the image (click it to enlarge) above, you’ll notice a familiar folder structure in the upper part of the Regulatory Reports screen – it looks just like Windows Explorer and works similarly. It allows you to drill […]

  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. 

A major part of the case management process is to ensure that every adverse event term is coded appropriately to the medical dictionary MedDRA. Oracle’s Argus Safety makes coding verbatim terms quite simple. The system integrates very smoothly with the medical dictionaries MedDRA and WHO Drug. Per current MSSO Points to Consider (MSSO, 2014), adverse […]

In a previous post, we discussed that Oracle’s Argus Safety makes entering and managing adverse event cases relatively simple due to its intuitive user interface. For this post, we’ll discuss working in the event and product assessment screen and look at a few of its key features. One main requirement for any safety system is […]

The electronic (or manual through the Safety Reporting Portal) reporting of post-marketed individual case safety reports (ICSRs) to the FDA will be required by mid-2015 (FDA, 2014), and the most efficient way to perform such activities is through an industry-proven adverse event reporting system, such as Oracle’s Argus Safety. Since this is the safety and […]