Posts Tagged ‘remote monitoring’

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. 

CROs, Take Note! Clinical Trial Monitors Are Ditching Their Jobs

  According to FierceCRO and a new report by HR+Survey Solutions, a quarter of clinical trial monitors in the U.S. are ditching their jobs for more lucrative ones. The 2016 CRO Industry Global Compensation and Turnover Survey report, which includes responses from 24 public and private contract research organizations (CROs), indicates that over the last […]

Risk-Based Monitoring, In Layman’s Terms

One of my LinkedIn contacts shared the video Risk-Based Monitoring vs Remote Monitoring Finally Explained, in which Dan Sfera of www.theclinicaltrialsguru.com explains both concepts in layman’s terms. In essence, the idea of Risk-Based Monitoring (RBM) is to leverage the data in existing IT systems to spot, rectify, and prevent issues relating to the execution of […]

Top 5 Technology Trends in Healthcare – August 2013

The healthcare IT field is rapidly developing and changing. Emerging technology and updated regulations put pressure on healthcare providers and health plans to stay ahead of the curve. Perficient creates a monthly list that explores some of the current topics and issues in health IT. This list examines the most talked about issues and technologies […]

Top Technology Trends in Healthcare – June 2013

The healthcare IT field is rapidly developing and changing. Emerging technology and updated regulations put pressure on healthcare providers and health plans to stay ahead of the curve. Perficient creates a monthly list that explores some of the current topics and issues in health IT. This list examines the most talked about issues and technologies […]

3 Great Examples of Telehealth – Robots Optional

The healthcare industry is experiencing revolutionary changes stemming from the rapidly shifting role of the patient within the continuum of care. This is resulting in high demand for easier access to healthcare professionals, access to online medical information, and alternatives to traditional care. There are few other places where this market shift has been more […]