A new U.S. Food and Drug Administration (FDA) guidance seeks to help clinical trial practitioners ensure the safety of patients while maintaining compliance with good clinical practice (GCP) and otherwise […]
“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 new […]
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 professionals around the world […]