Topic: Risk Based Monitoring

Risk-Based Monitoring Update: a Message from the RBM Soapbox

As readers of this blog know, Health Decisions embraces risk-based monitoring. Nevertheless, we keep an eye out for issues encountered in the field. A recent post by Nadia Bracken in her RBM Soapbox feature at ClinOpsToolkit raises an important issue sometimes encountered when putting risk-based monitoring into practice. Nadia writes as follows:      Every time I… Read more »

Risk-Based Monitoring: Cost and Quality Implications

Moe Alsumidaie’s report on the BMS pilot project referenced another of hist interesting ACT blog post about Amgen’s approach to risk-based monitoring. (Our thanks to Alsumidaie and ACT Editor-in-Chief Lisa Henderson for an outstanding job tracking Big Pharma’s transition to RBM.) Amgen’s approach to RBM keeps centralized monitoring in-house and outsources onsite monitoring on a… Read more »

Risk-Based Monitoring: Looking to History vs. Focusing on the Current Trial

Perhaps the BMS risk-based monitoring pilot project referenced in last week’s post focused so intensely on gathering historical information as a basis for developing risk-based analytical assessments, KPIs and KRIs that the project ream had little opportunity to address process improvement, technology development and staff training and development. If so, this raises two questions: Without… Read more »

Health Decisions at DIA: LiveTrial Demo, Risk-Based Monitoring and GoPro HERO 3+ Videocam

Vice President Clinical Affairs Dr. Patrick Phillips will lead a Health Decisions team at the DIA 50th Annual Meeting in San Diego June 15 – 19. Patrick looks forward to discussing the essentials and nuances of risk-based monitoring implementations with DIA attendees, as described in this press release. The DIA program lists 13 sessions on… Read more »

Risk-Based Monitoring: Pilot Projects, Functional Service Providers and Integrated Solutions

An informative recent post by Moe Alsumidaie of Annex Clinical on the Applied Clinical Trials blog, “How Bristol-Myers Squibb is doing Risk-Based Monitoring,” briefly described what the BMS risk-based monitoring pilot project has accomplished as well as issues encountered during implementation. It is nice to see a big company like BMS getting involved in RBM…. Read more »

The Next 25 Years in Clinical Research: Learning to Learn Faster

Missed Opportunities to Advance Clinical Research 605 BCE In Nebuchadnezzar’s court, Daniel and friends conducted a controlled trial comparing the effects of a meat-and-wine diet to Daniel’s preferred fare of lentils and water. King James Bible, Daniel Chapter 1 560-547 BCE Croesus, King of the Lydians, conducted a blinded controlled test of the accuracy of… Read more »