Posts Tagged ‘pharma’

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

  While some of you might be hoping that RBM is just a trendy idea that we’ll soon forget, I have to say that when regulatory agencies take the time to draft and produce guidance documents on the topic… 

  When we think of compliance, we think of consistency. Compliance depends on following the same processes and procedures over and over, across the board. After all, that’s why we have all of those SOPs, right? When we’re used to conceptualizing compliance this way, the notion of risk-based monitoring can certainly lead to cognitive dissonance. […]

  Because risk-based monitoring does not involve 100% source data verification (SDV), unlike traditional monitoring, it’s understandable that RBM could seem sort of like “cheating.” But, research has shown that 100% SDV does not consistently result in higher quality data. In other words, the cost of 100% SDV outweighs the potential benefits. 

  In RBM, not all sites are monitored the same way and not all source data is 100% verified. This can make it seem like the monitoring that IS happening isn’t as rigorous or in-depth as it should be…with “should” being the operative word. 

  When site personnel hear that their sponsors have switched to RBM and will no longer be sending monitors at regular intervals throughout the study, they might feel like they’ve been abandoned and that now the burden of executing the study perfectly is 100% on them. Au contraire, my friends! In an RBM strategy, sites […]

  Key findings in a new Gartner report showed that cloud computing is likely to grow 16.5% in 2016, reaching $204 billion in spending. According to Sid Nag, director, cloud technologies at Gartner Research, “The market for public cloud services is continuing to demonstrate high rates of growth across all markets and Gartner expects this […]

  If there’s a time for pharmaceutical and medical device companies to seek more real world data as evidence to support their medical products, that time is now. Real world data, which is the data generated in settings such as routine doctor visits and hospital stays, is often found in electronic health records (EHR) and […]

  While it’s true that both terms include “monitoring,” it’s not true that they’re synonymous. In fact, remote monitoring is actually a subset of risk-based monitoring – a type or form of monitoring, rather than a monitoring strategy, like RBM. 

  If you’ve been waiting to implement Argus Safety 8.x or upgrade your existing environment, the wait is finally over. While the new version was released last year, it takes several months to build a comprehensive validation suite, and I’m happy to announce that Perficient’s life sciences group has completed that task. On top of […]

  Following an 18-month-long investigation by the United States Senate Committee on Finance, Gilead’s pricing and marketing strategy for its hepatitis drugs, Sovaldi and Harvoni, was deemed one that chooses profit over patient access. In order to appropriately shape policy related to these findings, the Committee has written a letter to the healthcare and patient […]

  Just hearing the word “risk” can make people feel anxious, so it’s natural that the term “risk-based monitoring” conjures up concern. But, in reality, RBM is actually about mitigating risk in clinical trials.