Posts Tagged ‘drug safety’

  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. 

  I’m not going to get into whether prescribing or using drugs for off-label purposes makes sense – you can decide that for yourself. However, what I will tell you is that it’s a hot topic in the industry right now. Pharmaceutical companies continue to lobby the FDA to eliminate any prohibition of off-label promotion […]

  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. 

  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 a post from earlier this year, Medical Coding In Argus Safety, Perficient’s Dr. Rodney Lemery discussed how Oracle’s safety and pharmacovigilance (PV) system integrates very nicely with MedDRA and WHO Drug. Since much of the work our safety and PV team does revolves around Argus Safety, we’re also heavily involved with the installation […]

  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 […]

  Now that May 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 April – they’re ranked in order of popularity, with number one being the most viewed piece. 

  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. 

  Most of us have searched for information about pharmaceuticals on the web and, more often than not, wound up on a website that provided general information about the product. Such sites are usually sufficient enough to answer basic questions. But, what if there were a site that offered more? What if there were a […]