Posts Tagged ‘clinical trials’

  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. 

  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. 

  Data privacy across all industries continues to be a big concern for everyone. When it comes to the life sciences and healthcare industries, patients are especially worried. They simply are afraid of being identified. In a recent Scientific American article, Adam Tanner discussed the business of buying and selling health data. Health data brokerages […]

  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. 

It’s no secret that patients struggle with taking their medication. Whether they forget or purposely avoid taking it, a patient’s outcome could be affected. If a patient is in a clinical trial and isn’t following protocol by taking their medication as instructed, it ruins the legitimacy of the trial’s data and ultimately puts other lives […]

  Last year, I wrote about Proteus, the company behind the FDA-cleared ingestible sensor that helps monitor patients’ adherence to medication. At that time, the company was running clinical trials in the US, whereas in 2012, the company’s platform was already deployed in the UK. 

  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 […]

  Several days ago, I wrote about how the life sciences industry, including government organizations, is struggling when it comes to the reporting of clinical trial results to the ClinicalTrials.gov database. Unfortunately, other issues plague the industry, including one that The New York Times reported on January 14, 2016. The Government Accountability Office (GAO) found […]