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Wednesday, September 29 • 9:00am - 9:30am
TRACK A: Case Study of 100% Virtual COVID-19 Vaccine Trial

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Journey Through the Development, Design and Execution of a Completely Remote COVID-19 Vaccine Trial 
  • Discuss the biggest challenges to clinical quality due to the necessary remote nature and how they were overcome
  • Evaluate clinical data flow and how integrity was documented
  • Detail the QA audits and GCP compliance oversight that was provided
  • Compare the execution of remote site and vendor audits and to pre-COVID norms

Speakers
avatar for Maryann Livolsi

Maryann Livolsi

Senior Director, GCP Quality Assurance, BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE
Accomplished leader in R&D Quality Assurance with effective management experience worked in small, mid-sized, large pharmaceutical/bio-pharmaceutical and a non-profit bio-pharmaceutical company, in depth knowledge in clinical trial management, GXP auditing, process gap analysis, SOP... Read More →


Wednesday September 29, 2021 9:00am - 9:30am EDT