Posts Tagged ‘drug safety system’

  Now that June is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in May – they’re ranked in order of popularity, with number one being the most viewed piece. 

  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. 

  I recently stumbled upon the picture on the right on LinkedIn and it reminded me of a conversation that I had with my mother, who is an architect by trade. She told me that many roads came to be what they are today, not by well-thought-out plans, but rather by people and animals getting […]

  I was recently listening to the radio and heard about a book “Who Knew?: Things You Didn’t Know About Things You Know Well” and it reminded me of a story that that our safety and pharmacovigilance director, Dr. Rodney Lemery, told during a webinar earlier this year. Where did the name Argus Safety come […]

Attaching files to a case is an important aspect of case management work processes. Typically one would attach source documents here, such as a discharge summary report, a hospitalization record, patient laboratory records, etc. Without formal integration to a document management system, it’s quite easy to maintain safety source documentation by attaching a file in […]

Whether you’re using Oracle’s drug safety and pharmacovigilance solution, Argus Safety, a different application from another vendor, or even Excel to capture and manage adverse event data, our January 29th webinar, Features of a World-Class Safety System may be of interest. Dr. Rodney Lemery, the director of Perficient’s life sciences safety and pharmacovigilance division, is […]

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 […]

Validation. Admit it – you cringed a little. It’s almost like a dirty word in our industry. That thing that slows down system implementations. That thing that adds a bunch of time and cost to IT projects. That annoying, but necessary, evil. Well, okay, it’s not really “evil,” per say. It is, after all, designed […]

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 […]

Last time, we concluded that the costs associated with hosting clinical trial software in the cloud can actually be less than for on-site solutions. In this post, we’ll tackle access to data and system uptime. Claim #4: Clinical or safety data stored in the cloud can be accessed at any time. Fact or fiction? Fact. […]

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 […]

The pharmaceutical and medical device industries continue to be under close scrutiny by the FDA when it comes to product safety and the reporting of adverse events. With stringent regulatory requirements that’ll make any company or patient cringe, there’s no way to hide from authorities. And, rightly so. But, guess what? There are also adverse […]