Understanding that site management organizations (SMOs) are essentially the bridge between the sponsor/contract research organization (CRO) and sites, we will demonstrate proven quality improvement practices used by SMOs to reduce start-up timelines. Roles discussed involve study activation, regulatory compliance, contracting and budgeting, clinical education, and clinical trial management system oversight. Participants will understand the function of each role and how the delineation of responsibilities improves site compliance, data quality, and sponsor/CRO satisfaction with a site's clinical trials. We will explore best practices using specific examples from real-world experiences, including technology use and templates covering communication, trial management, study and site specifics, etc.
CEU: 1.00 ACRP
Speakers:
Charita Braker, Manager, Clinical Research Education, HCA Healthcare Research Institute
Jessi Klindedinst, Manager, Regulatory Affairs, HCA Healthcare Research Institute
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Study & Site Management Journey Sponsor
