PUBLICATIONS

ISO 9001:2015 and ICH GCP E6(R3): Two Standards, One Language of Quality in Clinical Research Why these standards matter In today’s clinical research landscape, quality is not optional — it is the foundation of trust between sponsors, CROs, regulators, and, ultimately, patients. Two major frameworks set the tone: ISO 9001:2015, the world’s most widely adopted quality management standard, and ICH GCP E6(R3), the latest revision of Good Clinical Practice, finalized Read more

Clinical Research Focus. 44th Edition NIH Scientists Advance Gene-Editing Approach for Late-Onset Tay-Sachs NIH researchers have successfully used gene-editing to boost enzyme activity and ease symptoms of late-onset Tay-Sachs in human cells and mice. This breakthrough could pave the way for future therapies targeting Tay-Sachs and other lysosomal storage disorders. Learn more Milestone Achieved: Cromos Pharma Earns ISO 9001:2015 Certification Read more

Rare Disease CRO Services: Precision in the Face of Unique Challenges Rare diseases, despite their individual scarcity, impact millions of lives worldwide and demand a specialized approach to drug development. With over 10,000 distinct rare diseases affecting around 400 million people globally, any single condition may involve only a handful of patients. This creates exceptional complexity for clinical trials, requiring operational agility, scientific innovation, and strong Read more

From Tariff-Free to Targeted: How the EU–US Trade Deal Puts Pharma in the Crosshairs The July 2025 EU–US trade agreement brought relief to many industries by averting a 30% U.S. duty on European goods. But for pharmaceuticals, the deal marked the end of a long-standing safe harbor. A new ceiling of 15% tariffs on EU exports, including branded medicines, has upended decades of tariff-free transatlantic trade and thrust the Read more