Planning for Quality in Medical Device Trials

Presented by

Kristen Welz and Vicki Gashwiler

About this talk

The concept of risk-based monitoring (RBM) has been discussed, implemented and refined in the pharmaceutical and medical device worlds for more than a decade. 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. In this webinar, the featured speakers 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 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
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