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ACRPtv — Spotlight On… Effective Quality Risk Management as a Mindset

Featuring Sam Sather, Vice President, Clinical Pathways “Every trial we do should be based on risk, especially human subject protection and data integrity,” says Sam Sather. Unfortunately, some practitioners minimize the importance of robust Risk Based Monitoring (RBM) programs, Sather says in our July 6, 2020 interview. “It’s the way we should be doing all […]

Promising Treatment for Slowing Kidney Disease Falters in Clinical Trial

Historically, half or more of people with type 1 diabetes develop kidney disease, which frequently progresses to kidney failure requiring hemodialysis or a kidney transplant for survival. The high rate of this diabetic complication has dropped slightly in recent years, but is still a huge problem, says Alessandro Doria, MD, PhD, MPH, senior investigator in […]

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FDA Guidance Provides COVID-19 Vaccine Approval Parameters

While the U.S. Food and Drug Administration (FDA) is obviously supportive of the most expedient means to find a vaccine for COVID-19, new guidance for industry puts some parameters on the agency’s regulatory elasticity. “Vaccines licensed in the United States must meet the statutory and regulatory requirements for vaccine development and approval, including for […]