PUBLICATIONS

From Oysters to Orthopedics: China’s “Bone-02” Bio-Glue Redefines Fracture Repair Researchers at Zhejiang University’s Sir Run Run Shaw Hospital have unveiled Bone-02, a biomimetic “bone glue” capable of repairing complex fractures in just three minutes. The innovation was inspired by oysters’ remarkable ability to adhere to rocks underwater — a challenge long considered impossible to replicate in human physiology. How it works Unlike metal plates Read more

CRO Regulatory Affairs: Bridging Strategy, Compliance, and Speed Bringing a new therapy to patients is as much a regulatory journey as it is a scientific one. Every submission, meeting, and document must align perfectly with evolving international standards — from FDA INDs and NDAs to EMA CTIS, IMPDs, and the EU CTR framework. At Cromos Pharma, we view regulatory affairs not as an Read more

Clinical Research Focus. 45th Edition Trump Administration Weighs “Severe Restrictions” on U.S. Drug Licensing from China According to a New York Times report, the Trump administration is considering a draft executive order that would impose stricter oversight on U.S. pharmaceutical deals with Chinese biotech firms, including national security reviews of licensing agreements and tougher scrutiny of Chinese clinical trial data Read more

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