Posts Tagged ‘pharmacovigilance’

  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 […]

<   The work we’re doing for life sciences and healthcare companies continues to pay off. And, Oracle thinks so, too. We recently received an award from Oracle’s Health Sciences Global Business Unit for the work we’re doing with their clinical and pharmacovigilance applications. 

Editorial Credit: Gil C / Shutterstock.com Analyzing Google searches to uncover previously unknown adverse events isn’t news, per se, but it looks like it could be gaining traction with the FDA. According to a recent Bloomberg article, the FDA’s public calendar shows that several employees from Google met with the FDA to discuss the possibility […]

  As long as you have the experience listed in the job descriptions. But, to put it simply, if you’ve worked in the life sciences industry, you’re already ahead of the game. Check out the job openings we have on our life sciences team and apply if you’re interested. We’ll keep your application secret. Promise. […]

  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 […]

  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 […]

  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 […]

  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 […]

  As you may have read in our most recent “cloud fact or fiction” post, we confirmed that companies have the ability to perform system administration activities for solutions hosted in the cloud. Let’s now tackle configurations and customizations. 

  It’s not uncommon for sponsors and CROs to perform version upgrades on their clinical and safety systems or move away from certain ones altogether. They’ve been doing it for years. But why, when it impacts so many different parts of a company, both operationally and financially? The answer is relatively simple: Because what’s at […]

  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. 

  In our last “cloud fact or fiction” post, we discussed integrating systems that are deployed in the cloud. This week, let’s talk about system administration. Claim #8: Choosing a hosted clinical or safety system means relying on the vendor for system administration tasks.