Posts Tagged ‘Risk-Based Monitoring’

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Perficient and Lokavant Partner To Deliver Next-Generation Clinical Trial Operations Insights

Perficient is thrilled to announce a new partnership with Lokavant, a leading clinical trial intelligence solutions company. Lokavant’s solution aggregates and harmonizes clinical trial data, helping customers gain a more comprehensive understanding of how their trials are performing operationally. “Our partnership with Lokavant will greatly benefit our clients,” said Param Singh, director of clinical operations […]

How To Fix Cumbersome Site Monitoring Visits To Clinical Sites

While sponsors, contract research organizations (CROs), and clinical sites all acknowledge that site monitoring is a necessary part of ensuring clinical trials are run in compliance with governing regulations and protocols, it can be a rather burdensome process, both for monitors and for sites. Monitors struggle with scheduling the visits, having access to everything they […]

How To Make Site Monitoring Reports Easier And More Transparent

Imagine with me: Based on predefined clinical data and milestones, a site monitor receives a notification that one of her sites requires a site monitoring visit. She works with the site to schedule the visit, and both she and the site receive automated confirmation emails. The day of the visit, the monitor arrives at the […]

Deploying Risk-Based Monitoring (RBM) Strategies

  In a time when the turnover rate for clinical monitoring positions in the U.S. hovers around 25%, it’s more important than ever to do more with less. With risk-based monitoring (RBM), contract research organizations (CROs) and sponsors can leverage data in existing IT systems to spot, rectify, and prevent issues related to the execution […]

Answers To Questions From Risk-Based Monitoring (RBM) Webinar

  On January 14, 2016, Perficient hosted a webinar titled Leveraging Siebel CTMS for Risk-Based Monitoring. We received some good questions during the webinar and figured we’d share them (and the answers) with you. 

Is Risk-Based Monitoring Just A Fad?

  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… 

Is Risk-Based Monitoring Compliant?

  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. […]

Does Risk-Based Monitoring Cheat In Source Data Verification?

  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. 

Is Risk-Based Monitoring Rigorous Enough?

  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. 

Does Risk-Based Monitoring Shift The Burden Onto Sites?

  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 […]

Is Risk-Based Monitoring The Same As Remote Monitoring?

  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. 

Does Risk-Based Monitoring Increase Trial Risk?

  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. 

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