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Workshop D: Relationship Management and Oversight
Wednesday September 25, 2024 1:00pm - 4:30pm EDT
Define the Scope of Responsibilities of the Trial Sponsor and Outsourced Partners, and Strategies for Optimizing the Relationship to Ensure Clinical Success

​As regulatory authorities continue to focus on demonstrating oversight, to ensure you are inspection ready, we first must understand what those responsibilities are, who is responsible, and how is it documented.   

Learning outcomes  
  • Clearly outline the operational and compliance responsibilities of the trial sponsor compared with those of the CRO 
  • What are the common misconceptions?     
  • Evaluate best practices for overseeing your clinical partners and how and when to establish that  
  • Discuss the functional area(s) that should be responsible for oversight at the trial sponsor and what that looks like  
  • Analyze strategies for documentation and what kinds of agreements need to be in place with clinical partners  
  • Identify inspection findings related to oversight and what could have been done differently  
Speakers
avatar for Penny Bristow

Penny Bristow

President, CORE Clinical Solutions, LLC
Over 30 years experience in many aspects of oncology clinical research. Broad experience in clinical development gives me a generalist perspective with a focus on cross-functional integration. We provide a flexible, client-centered scope of services to achieve your success. A specialty... Read More →
avatar for Leila Cupersmith

Leila Cupersmith

Founder, CEO, and Principal Consultant, Choice ClinOps, LLC
As the owner of ChoiceClinOps, my focus is on providing expert consultation for phase 1-3 global oncology clinical trials, ensuring they are conducted with the utmost precision, from start-up to close-out. Our team excels in managing intricate operations, evaluating suppliers, and... Read More →
avatar for Beata K. Glogowska

Beata K. Glogowska

Founder, CEO, and Principal Consultant, Indigo SEA Biotech Solutions, LLC
Beata is an Industry Leader, Polymath, and Passionista with over 20 years of experience in Clinical Research Program Development, Project Management, Analysis and Strategy. She is the Founder of Indigo SEA Biotech Solutions LLC, a rising woman-owned business providing consulting... Read More →
Wednesday September 25, 2024 1:00pm - 4:30pm EDT
  Workshop

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