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50,000 Participants, Two Countries, One DCT: Oversight That Worked
Session Chair(s)
Leslie Sam
President
Leslie Sam and Associates, LLC, United States
50,000 participants across two African countries created oversight challenges no checklist could handle. Learn how operational design and informal KRIs shaped oversight—and dual perspectives from operations and quality.
Learning Objective : Differentiate traditional monitoring from risk-proportionate oversight in mega-scale DCTs; Analyze how operational practices reflected RBQM and QbD principles without labels; Design fit-for-purpose monitoring approaches informed by informal KRIs and real-time signals.
Speaker(s)
Panelist
Lisa Collins
Innomas Clinical Research (Africa), Nigeria
Founder - Head Clinical Operations
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