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3rd Clinical Quality Oversight
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Thursday, May 23 • 1:00pm - 1:30pm
SMALL COMPANY CASE STUDY: A RETROSPECTIVE VIEW OF A FAILED PARTNERSHIP

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Learn from a Small Company's Experience Uncovering Multiple Misconduct Issues at the CRO and Site Levels and what Actions Could Prevent a Similar Situation  
  • Establish case study background and the heavy reliance on the CRO/CRA 
  • Discuss how issues were uncovered and what could have been done differently 
  • Outline the decision to bring monitoring in-house and what that entailed 
  • Evaluate the outcome, impact to trial integrity, and what actions/processes are now in place as a result 
Speakers
avatar for Elizabeth Polvent

Elizabeth Polvent

Senior Director, Clinical Operations, ARTHROSI THERAPEUTICS, INC.
In the dynamic realm of pharmaceutical R&D, where every decision counts and every action can have significant downstream consequences, Elizabeth’s extensive 20+ year career is marked by a relentless pursuit of high-quality data and a steadfast dedication to ethical practices. From... Read More →
avatar for Pamela Mundell

Pamela Mundell

Clinical Trial Manager, ARTHROSI THERAPEUTICS, INC.
Pamela Mundell is a Clinical Trial Manager specializing in Phase II and Phase III trials in the pharmaceutical and biotechnology industry.    Leveraging her understanding of global regulatory requirements and best GCP practice,  she oversees the planning, execution and monitoring... Read More →


Thursday May 23, 2024 1:00pm - 1:30pm EDT
  Included in VIRTUAL Experience