Marin Richeson

  On Tuesday, March 1, 2016, after being very ill for several days, I asked my husband to take me to the emergency room. I had been unable to keep food or drink down, and I had a very painful swollen mass in the right side of my neck/throat. In the ER, they determined that […]

  Not long ago, Perficient’s clinical trial solutions team completed a project for a client that integrated our clinical trial management system (CTMS) accelerator, Siebel Clinical ASCEND (ASCEND), with Veeva Vault eTMF (Veeva). The idea for the integration stemmed from a desire to increase efficiency and user satisfaction, while reducing human error. 

  We’ve written extensively about the many ways in which life sciences companies can leverage a clinical trial management system (CTMS) like ASCEND, Perficient’s pre-configured and enhanced version of Siebel Clinical. Why? Two reasons. For one, we are arguably the best implementer of Oracle Health Sciences applications for sponsors and CROs. And, two, ASCEND is […]

  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 […]

  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. 

  If you’re in the market for a clinical trial management system (CTMS), here’s a Top 10 countdown of reasons why you should choose ASCEND. 

  We’ve done it so many times, we don’t even have to think about it anymore. We’ve got our Siebel CTMS implementation process down pat and it’s marvelously efficient. How do we do it? It starts with our pre-configured version of Oracle’s Siebel Clinical, something we call ASCEND. Combine ASCEND with our hosting services, and […]