The World Health Organization (WHO) has released new draft guidelines on good manufacturing practices (GMPs) for investigational therapeutics that impact clinical trial operations. Drugs used in clinical trials should be […]
Women remain underrepresented in cardiovascular clinical trials despite guidelines and legal requirements developed almost 30 years ago to ensure broader inclusivity, according to recent reports in the Journal of the […]
Working with a wobbly institutional review board (IRB) is like “building a house on sand,” says Elizabeth Nelson, president of Regulatory Risk Management, LLC. Unfortunately, many clinical trial practitioners can’t […]
The clinical trial industry is clearly warming to the ideas behind decentralized clinical trials (DCTs), but it is ultimately patients who will drive the rate of adoption, says Dave Kelleher, […]
A second U.S. Food and Drug Administration (FDA) Warning Letter has been issued to a firm for alleged ClinicalTrials.gov reporting noncompliance violations. Georgia-based Accuitis, Inc. could be “subject to a […]