Life Sciences

  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… 

  According to an article in Clinical Leader that featured Bayer Healthcare’s VP Global Strategy & Development Advisor, by evaluating certain criteria against patient populations, electronic health record (EHR) systems can help sponsors determine trial feasibility and shape better study protocols. This can reduce the number of amendments, which can cost anywhere from $300,000 to […]

  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. […]

  Not long ago, our team published a guide on Google Search for Life Sciences because the Google Search Appliance (GSA) can work wonders for companies in our industry. But we just learned that Google has decided to put that powerful yellow box, designed to sit on-premises, to bed. Let me say that again: Google […]

  It’s often said that “music heals.” While it may not cure disease, some nations are turning to music in an attempt to prevent it. Jamaica’s Ministry of Health produced a reggae music video that’s about Zika, a virus that is spread through mosquito bites. According to the Center for Disease Control (CDC), Zika is […]

  Let me preface: this is just me playing devil’s advocate. To be fair. To give a different perspective. There is an exorbitant amount of conversation going on about the sharing and publication of all clinical trial data, good or bad. The reason? To help others out. To advance science. To save lives. 

  Efficiency and compliance are two critical components in highly-regulated industries, especially when it comes to developing drugs and medical devices. Unfortunately, though, these are two areas in which many life sciences companies struggle and could significantly improve through IT solutions. 

  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. 

  Gartner forecasts that the business intelligence (BI) and analytics market will increase 5.2% over last year, reaching $16.9 billion by the end of 2016. Ian Bertram, managing vice president at Gartner, believes “The shift to the modern BI and analytics platform has now reached a tipping point.” He urges the organizations that are lagging […]

  Recruiting subjects for clinical trials has been a longstanding challenge for pharmaceutical and research organizations. According to Dr. Steven Alberts, Chair of Medical Oncology with the Mayo Clinic, only 5% of cancer patients ever enroll in a trial. On top of that, only a fraction of all trials ever finish enrolling enough patients on […]

  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. 

  A few weeks ago, an opinion piece was featured on the international public broadcaster Deutsche Welle’s website. In her article, the author shared the “unfair” standards by which pharmaceutical companies are frequently judged.