Posts Tagged ‘medical device’

  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 […]

  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. 

  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. 

  Most digital transformation initiatives begin with customer journey mapping, a process that helps fully understand the dynamics of your target customer and their behavior. Journey mapping connects the dots from your customer’s initial interaction with your brand, through their entire experience with your brand via multiple channels (e.g., website, mobile app, phone call, direct […]

  Risk-based monitoring (RBM) continues to be a hot topic among sponsors and contract research organizations (CROs) for a variety of reasons, including the time- and cost-savings it can offer, as well as its ability to help keep patients safe. Last week, Ashok Ghone, Ph.D., vice president of global services at MakroCare USA, wrote a […]

  In today’s digital age, consumers have evolved to become far more independent and self-sufficient. They now expect access to information, services, and products to be quick, easy, useful, engaging, and even entertaining. Businesses that are not yet meeting these new expectations are falling behind the curve. 

  According to IBM, we generate 2.5 quintillion bytes of data every day. And, 90% of the data that exists today, whether found in your clinical systems, on social media, or on your mobile devices, has been gathered within the last two years. All of that is what we call “big data.” As the volume […]

  Outside of work, it’s obvious that we have become a digital society. We use mobile devices to guide us through rush hour traffic, to find a great new spot for lunch, to research recipes for dinner, to do our shopping, to track our exercise, to entertain our children (and ourselves!), to connect with friends […]

  In the good ol’ days, walking in the clinic door and asking for a few minutes of a physician’s time was the main method used by sales reps to position a drug in the doctor’s mind. Physician outreach was, and still is, one of the most effective ways to penetrate the market with a […]