Planning for Quality in Your Medical Device Clinical Trials

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.

In this webinar, the featured speakers 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

Speakers

Vicki Gashwiler, Executive Director, Strategic Development, Medical Device & Diagnostics, Premier Research

Vicki Gashwiler joined Premier Research in 2019 as the executive director of strategic development in the Medical Device & Diagnostics group. She brings over 13 years of experience in the medical device industry, both on the sponsor and CRO sides. Prior to her industry experience, Vicki began her career as a registered nurse in 2000, working on cardiac, critical care and out-patient orthopedic surgical units. She started her industry career as aclinical research associate at Abbott Vascular and had the opportunity to advance in the operations group as a clinical trial manager and then as a project manager. During her time at Abbott Vascular, Vicki supported global clinical trials spanning across Europe, Canada, Latin America, Australia, the US and the Asia-Pacific. Her time at Abbott provided her an extensive understanding of complex trial execution on a global scale, diverse team management and global regulatory processes and timelines.

In 2014, Vicki joined Novella Clinical in a project manager role, gaining experience on the vendor side of clinical trial delivery. She filled roles of increasing responsibility while at Novella, including senior project manager,program director, associate director and director of Strategic Development & Market Access. During her time at Novella, Vicki gained experience in oncology and dermatologic devices, endocrinology, weight management, orthopedics, as well as additional cardiac and vascular device trials. Vicki brings a high level understanding of market development and trends as well as a deep therapeutic knowledge of many disease processes and the clinical trials to intervene upon them.

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Kirsten Welz, Project Leader, Medical Device & Diagnostics, Premier Research

After graduating with a degree in biology, Kirsten started her career in clinical research in 2002 as a clinical research associate. Over time, she progressed to a clinical trial leader role then clinical project manager. These steps allowed her to gain broad experience in the field of pharmaceutical and medical device studies as well as deep insight into different indications and national regulations. She worked for several years as an independent consultant, covering positions like CRA, clinical project manager, GCP-trainer for study sites and CRAs, quality manager and other supportive functions for inspection preparations. She also has experience working for sponsor companies and CROs.

Since 2013, she worked as a clinical project manager at NAMSA, fully dedicated to pre-market and post-market medical device studies conducted mainly in the US, Europe and Asia Pacific. Next to her project management role, she was also involved in medical writing, site auditing, regulatory activities and acted as trainer for sites and CRO staff. Kirsten is currently working as project leader at Premier Research, focusing on medical device studies. Her main therapeutic experience is in cardiology with special focus on interventional cardiology to treat coronary artery diseases, mitral valve insufficiencies or atrial fibrillations.

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