Jun 30, 2021
Sponsors should approach Risk-Based Quality Management (RBQM) implementation focusing on supporting some important critical factors, including company culture, trial design, trial operations, as well as continuous improvement. That’s one of the key takeaways from Sam Sather’s interview with Linda Sullivan, MBA,...
Jun 14, 2021
With the anticipated adoption of ICH-E8-R1 this summer, there’s going to be even more attention on patient voice and engagement and critical-to-quality factors. MCC’s Quality by Design (QbD) - Risk Based Quality Management (RBQM) – Quality Improvement community of practice group is has already developed practical...