As guidance for Industry has evolved, ICH E6 (R2) for example, presenting new recommendations for ensuring patient safety, organizations have faced significant challenges in translating the guidance into tangible operating practices to satisfy the requirement of an entirely Risk-Based Approach to Study Execution (RBx). Being the leader in Risk-Based Quality Management Solutions, we’ve garnered a wealth of experience in the space, perfectly positioning us to offer support in preparing for site inspections and implementing Risk-Based Monitoring (RBM)/Risk-Based Study Execution (RBx).
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Tufts CSDD Impact Report
This study takes a proactive approach to understanding the dynamics between the enthusiasm around and adoption of RBQM, designed to enhance clinical trial quality and efficiency.
RBQM Adoption & ICH E6(R3) Updates
This recorded webinar dissects the Tufts CSDD Impact Report as well as new clinical trial execution models and ICH E6(R3) regulatory guidance updates.