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3rd Clinical Quality Oversight
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Thursday, May 23 • 1:30pm - 2:00pm
CASE STUDY: TRADITIONAL TO RISK-BASED

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Examine a Mid-Study Shift from Traditional Monitoring to a Holistic Risk-Based Approach and the Hidden Cultural Barriers to Compliance that it Uncovered
  • Detail the background for a Decentralized Malaria trial in Mozambique and Kenya
  • Discuss observed quality concerns and what actions needed to take place
  • Identify the elements of oversight that were missing and required to result in usable data
  • Outline cultural biases unique to certain communities impacting the quality of the data
  • Redesign the trial applying a holistic and adaptable risk-based approach to monitoring that resulted in proactive issue identification 


Speakers
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC
Accomplished, results-driven, passionate CLINICAL RESEARCH AND QUALITY PROFESSIONAL with over 20+ years of transferable technical and leadership skills [business acumen, interpersonal skills (verbal and written), Six Sigma Black Belt certification (CSSBB), Quality Improvement Associate... Read More →
avatar for Lisa Collins

Lisa Collins

Clinical Operations Expert in Nigeria
A dedicated Biotech and Pharmaceutical Leader with over 20 years experience in Clinical Operations and Drug Development Program Management. Managing multi-disciplinary globally distributed teams across North and South America, EMEA, South African and APAC regions, through multi-complex... Read More →


Thursday May 23, 2024 1:30pm - 2:00pm EDT
  Included in VIRTUAL Experience