Risk-based source data verification adoption reaches 96% in clinical trials, reshaping how monitors prioritize verification intensity across sites and...

Merry Life Biomedical starts Phase 2 trial of TML-6, an oral drug targeting autophagy-lysosomal pathways in early Alzheimer's disease...

Ivonescimab plus chemotherapy achieved a statistically significant overall survival benefit over durvalumab in biliary tract cancer Phase III trial...

European Commission approves obicetrapib, a CETP inhibitor for hypercholesterolemia, offering oral dosing and 41% LDL-C reduction in Phase 3...

Roche's enicepatide met Phase II endpoints in type 2 diabetes trial, demonstrating dose-dependent reductions in HbA1c and body weight...

Radial's FDA-cleared Evoke EEG integration across 27 brain medicine clinics tests whether distributed neuroimaging endpoints can survive real-world site…

PANXEON detects stage 1-2 pancreatic cancer with 87% sensitivity, but FDA's companion diagnostic pathway may be the bigger obstacle...

FDA Part 11 Compliance requires validated systems, audit trails, and electronic signatures linked to individual users. Learn what triggers...

Phase III Clinical Trials now generate 5.9M data points annually with 11% yearly growth, raising questions about managing protocol...

Wearable neuromodulation reduces AF recurrence after ablation in pilot trial, with 90% freedom from arrhythmias at six months versus...