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...
IASO208 in vivo CAR-T gains simultaneous FDA, NMPA IND approvals
IASO208 in vivo CAR-T gains simultaneous FDA and NMPA IND approvals, enabling Phase Ib studies across the U.S. and...
The $1M Trial Is Real. So Is the Question It Can’t Answer.
Lindus Health ran a Phase 2a neurology trial for $1M. Impressive, but AI's cost wins are hiding the problem...
FDA Would Rather You Relaxed the P-Value Than Dropped the Control Arm
At a Duke-Margolis and FDA workshop on rare disease statistics, an agency statistician made the trade-off explicit: a randomized...
Werewolf’s WTX-330 Shows Partial Response in Early Cancer Trial
Werewolf's WTX-330 shows partial response in early cancer trial, demonstrating manageable tolerability across dose escalation in Phase 1b/2 testing.
Faeth’s PIKTOR Posts 33% ORR and 7.4-Month PFS in Pretreated Endometrial Cancer
Confirmed ORR of 33%, rising to 44% in PIK3CA-mutant patients, with preliminary median PFS of 7.4 months. Faeth plans...