What the P2P Platform Trial Gets Right About Site Readiness That Most Sponsors Get Wrong
The Path to Prevention trial embeds Phase 2A learning cohorts inside PPMI's 7,755-participant infrastructure, here's what that means for...
A Child Died in a Gene-Editing Trial No One Reported. China’s 1,033-Trial Experiment Is Running Faster Than Its Safety Net.
A 6-year-old died after an unreported gene-editing trial at Shanghai Xinhua Hospital. With 1,033 CGT IITs active in China,...
The 39-to-1 Ratio Hiding Inside Your Significance Threshold
At the FDA and Duke-Margolis rare disease workshop, a statistician unpacked what a one-sided 0.025 actually commits you to:...
FDA Guidance Requires CNS Trial Assessments Classified as In-Person or Remote Before Enrollment
FDA guidance requires CNS trial assessments classified as in-person or remote before enrollment, with no case-by-case changes allowed during...
Capricor Files Q3 2026 Results Before Deramiocel FDA Decision
Capricor files Q3 2026 results ahead of deramiocel FDA decision on November 22 for its Duchenne muscular dystrophy cell...
Your Vendor Passed Qualification. Your Site Still Ran Out of Drug.
Regulatory certification of trial supply vendors doesn't prevent enrollment gaps. Here's where the operational oversight breaks down, and what...
Your Trial’s Primary Endpoint Is Missing Half the Patient: What Deep Learning Gait Analysis Reveals About eClinical Data Strategy
A Nature Medicine deep learning model predicts 12+ multisystem health phenotypes from gait alone, exposing a critical blind spot...
FSP Model Governance Requirements for Clinical Trial Outsourcing
FSP model governance requires sponsors to balance oversight obligations with operational capacity. Learn how to structure effective partnerships.
Definium’s DT120 ODT Meets Primary Endpoints in Two Phase 3 GAD Trials
DT120 ODT met primary endpoints in two Phase 3 GAD trials with effect sizes of 0.81 and 0.64, supporting...
Atea’s BEM/RZR Meets Non-Inferiority Against Epclusa in HCV Phase 3
Atea's BEM/RZR meets non-inferiority against Epclusa in Phase 3 HCV trial with 93.91% SVR rate, positioning the combination for...