“This is, indeed, like nothing I have ever experienced in 20 years of research,” says Laura Menck, CCRA, ACRP-PM, a clinical project manager in the U.S. for the Amsterdam-based health […]
Sponsors, contract research organizations (CROs), and sites should immediately introduce “emergency interim measures” to help sustain clinical trial monitoring as the coronavirus (COVID-19) continues to impact day-to-day life in the […]
A new guidance from the U.S. Food and Drug Administration (FDA) provides direction to sponsors on the evidence necessary to demonstrate the effectiveness of investigational new drugs (INDs) or […]
Why does it take so long to get new vaccines and medicines to market?
It is not a new question, but as governments, communities, and medical […]
The U.S. Food and Drug Administration (FDA) is collaborating with manufacturers of personal protective equipment (PPE) to help facilitate mitigation strategies related to the COVID-19 outbreak. “The FDA’s door […]