Life Sciences

  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. 

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: What about GAMP 5? How does it fit into 21 CFR? How to combine both? 

  Warnings letters stink, as they can impact a company’s image, stock value, and much more. That’s why companies should do everything in their power to make sure they follow FDA regulations to a “T.” 

  Last week, the FDA released a new draft guidance document called Adaptive Designs for Medical Device Clinical Studies. While the title specifically calls out “medical device,” the document states the following: 

  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 […]

  The pharma industry undoubtedly gets a bad rap. “Drug companies charge too much.” “They are only in it for themselves.” And it goes on and on. But are these accusations truly justified? In a recent Forbes opinion piece, John Lechleiter, Chairman, President, and Chief Executive Officer of Eli Lilly, brilliantly debunks the more common […]

  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 […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Is a web-based training system required to be Part 11 compliant? 

  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. 

  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 […]