“FDA recommends sharing your protocol and statistical analysis plan before the real-world study is conducted… to ensure the analysis wasn’t cherry-picked.”
MD
Meryl Dersarkissian
FDA Watch ·
“Do a cost versus benefit analysis... estimate of the return on investment of doing a ground up new process versus retrofitting an existing one.”
Jim Moran · The ISO Review Podcast · ISO 9001:2026 - Exploring the 10 Building Blocks of Quality Culture
Play from 15:56
15:56
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What was described
conducts a cost-versus-benefit analysis to decide whether to retrofit an existing process or build a new one from the ground up
Said nearby on the same subject
“We operate a team of 10 folks and every piece of software you see, we build ourselves from the ground up.”
♫
Said on TBPN
“You can set up a TRIS with 300,000... then roll back your existing one... accounts got 600,000 and then you start a new one with 600,000”
MM
Martin McGrath
Retire Right ·
“Vavilov should be adopted as the governing framework for reasonableness review... Kayla answered whether reasonableness review applies. Vavilov answers how it should be conducted.”
♫
Said on Supreme Court of Canada Hearings (English Audio)
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