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
Blue glowing pill splitting with electric crack, symbolizing disruption in pharma – Cromos Clinical Intelligence Report 50th Edition.
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
Global Oncology Trials, Local Relevance: Why the FDA Just Raised the Bar The FDA’s recent Complete Response Letter to Genentech’s BLA for Columvi (glofitamab) + GemOx in second‑line diffuse large B-cell lymphoma (DLBCL) has sent a crystal-clear signal: global trial data must be demonstrably relevant to U.S. patients. What Went Wrong? The phase III STARGLO trial enrolled 274 patients across 62 sites in 13 countries, but only 9% Read more

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