Planning for Quality in Your Medical Device Clinical Trials, New Webinar Hosted by Xtalks

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For more than a decade, this concept of risk-based monitoring (RBM) has been discussed, implemented and refined in the pharma and medical device worlds. Most large sponsor companies in the medical device industry have adopted RBM in their clinical trials. Meanwhile, smaller medical device companies, seem to be slower to embrace the concept. Despite years of conversation and availability of regulatory guidance from the Food and Drug Administration (FDA), European Medicines Agency (EMA), and ICH-GCP E6R2, these smaller organizations continue to be hesitant about adopting this tried-and-tested monitoring method.

During a live webinar on Thursday, March 28, 2019 at 11am EDT (3pm GMT), experts from Premier Research will discuss RBM — also referred to as quality-managed monitoring — and explore how to effectively implement this monitoring process into their medical device trials in a methodical and compliant way. They will show how this model can reduce costs and give a few examples of reporting and tracking tools that allow for better management of RBM.

Attendees will gain insight on:

  • How to build quality into clinical trials, from planning to reporting
  • Site management concepts — out of site does not mean out of mind
  • Specific monitoring procedures including:
  • Centralized monitoring
  • Targeted source data verification
  • Reduced monitoring
  • Remote monitoring
  • Key performance indicators in quality-management monitoring such as escalation triggers and documentation of quality actions

The informative session featuring Premier Research speakers Vicki Gashwiler, Executive Director of Strategic Development and Kirsten Welz, Project Leader, both from the Medical Device & Diagnostics division, includes a Q&A with the audience.

For more information or to register for this event, visit Planning for Quality in Your Medical Device Clinical Trials.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit
For information about hosting a webinar visit

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Candice Tang
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