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Posts Tagged ‘adverse event reporting’

U.S. Military Keeping A Close Eye On Supplements

  Megan Thielking from Stat News reports that a scientific journal took a close look at the impact nutritional supplements are having on U.S. military personnel. According to the article, 75% of people in the U.S. military take some type of dietary supplement every month. Since dietary supplements, such as weight-loss pills and multivitamins, don’t […]

A Hospital That Shares Mistakes For The Greater Good

  This struck me as interesting: The Boston Globe wrote an article on how doctors at Brigham and Women’s Hospital (BWH) are encouraged to share medical errors. In fact, they are asked to do so, knowing that the information will be published in a case study-like format for the public to see. The objective is […]

The Troubles With Adverse Event Reporting

  According to the September/October edition of the Impact Report released by the Tufts Center for the Study of Drug Development (CSDD), the reporting of adverse events (AEs) by healthcare professionals is inadequate. In particular, regulatory submissions are an issue due to the lack of critical information provided on submission forms, which can inadvertently alter […]

Analysis Finds Reporting Delays For Serious Adverse Events

  According to a recent research letter in the Journal of the American Medical Association (JAMA), an analysis of serious adverse event (SAE) reports from January 1, 2004 and June 30, 2014 (with certain exclusions) concluded that drug companies were more likely to delay the reporting of such instances within the required 15 calendar days, if […]

Activating Field Labels In Argus Safety

  One of the other major benefits of Argus Safety, Oracle’s drug safety and pharmacovigilance system, is the ability to maintain administrative tasks in an easy-to-use interface. The following blog post reviews some of the very simple possibilities of configuring Argus Safety to your own needs with minimal technical effort. 

The Yellow Card You Can’t Argue With

  You can’t argue with it because it’s a good idea. Yellow Cards have gone digital. Not the ones used in soccer/football, but the ones used in the UK for reporting adverse events. When governments undergo digital transformation, you know it’s not a fad. After all, they’re not typically early adopters…of anything. Last week, the […]

Accessing Previous Adverse Event Cases In Argus Safety

  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 […]

Argus Safety 8.0 Released! Reporting And Integration Heaven

  Coinciding with the Drug Information Association’s (DIA) 51st Annual Meeting in Washington, D.C. last week, Oracle announced the newest version of its drug safety and pharmacovigilance system. Argus Safety 8.0, considered a major release, offers new features and functionality to help life sciences companies comply with ever-changing global regulatory requirements. The Standard Edition of […]

A Google-Like Feature In Oracle Argus Safety

  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 […]

When The FDA Is Concerned About Your Ability To Monitor Drugs

  A couple of weeks ago, I wrote about a warning letter that was issued to a pharmaceutical company last month. I highlighted one of the FDA’s findings, which had to do with the company’s standard operating procedures (SOPs) having an insufficient amount of detail about their process for collecting adverse events. Today, I want […]

Report Generation And E2B Transmission Tracking In Argus Safety

  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 The System Fails To Keep Us Informed Of Adverse Events

  I just read “Failing To Report Severe Drug Side Effects: A National Embarrassment,” written by Forbes contributor Luke Timmerman. He talks about his recent personal experience with our health system and what he believes is poor adherence to the reporting of adverse events. Why should patients or their loved ones have to demand that […]

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