Unveiling 2025’s Biggest Site Challenges: Data-Driven Insights to Optimize Site Success

Clinical research sites are at a transformative juncture, facing heightened demands to deliver trials with greater speed, efficiency, and quality than ever before. As the industry embraces rapid innovation, digital transformation, and more complex protocols, pressures are intensifying at the site level, where budget constraints, funding cuts, and operational demands continue to grow. Today’s research sites must navigate a multifaceted landscape, contending with fragmented communications, persistent technology changes, and the need to recruit and retain skilled talent, among other obstacles.   

FDA Publishes ICH E6(R3): What it Means for U.S. Clinical Trials

The global clinical research community watched closely for the release of ICH E6(R3) Good Clinical Practice (GCP), the long-awaited update to the foundational guideline from the International Council on Harmonization (ICH). On September 9, 2025, the U.S. Food and Drug Administration (FDA) posted the final version on its website and published it in the Federal Register. This signals that the guideline is officially available in the United States and provides a clear reference point for industry and regulators alike.