The 90% Automation Promise Means Nothing to a Coordinator Running 12 Systems
Medable's CEO wants 90% of clinical trials automated by 2030. Site coordinators are still manually bridging 12 disconnected systems....
The Protocol-Only Coverage Analysis: What a Site Can Defend Before the Budget Arrives
A protocol-scoped MCA is a real deliverable, but it has hard limits. Here is what you can and cannot...
FDA’s 2026 Single-Trial Default Standard Reframes the Dual-Pivotal Debate for Sponsors Still Designing Phase 3
FDA's 2026 shift to a single pivotal trial as the default approval standard forces sponsors to rethink Phase 3...
Risk-Based Source Data Verification Adoption Rises to 96% in Clinical Trials
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 for Early Alzheimer’s
Merry Life Biomedical starts Phase 2 trial of TML-6, an oral drug targeting autophagy-lysosomal pathways in early Alzheimer's disease...
Ivonescimab beats durvalumab in biliary tract cancer Phase III trial
Ivonescimab plus chemotherapy achieved a statistically significant overall survival benefit over durvalumab in biliary tract cancer Phase III trial...
EC Approves Obicetrapib as Oral CETP Inhibitor for Hypercholesterolemia
European Commission approves obicetrapib, a CETP inhibitor for hypercholesterolemia, offering oral dosing and 41% LDL-C reduction in Phase 3...
Roche’s Enicepatide Meets Phase II Endpoints in Type 2 Diabetes Trial
Roche's enicepatide met Phase II endpoints in type 2 diabetes trial, demonstrating dose-dependent reductions in HbA1c and body weight...
What Radial’s 27-Site Brain Medicine Network Actually Means for EEG Endpoint Standardization
Radial's FDA-cleared Evoke EEG integration across 27 brain medicine clinics tests whether distributed neuroimaging endpoints can survive real-world site…
The Liquid Biopsy That Found Pancreatic Cancer Early Has a Bigger Regulatory Problem Than Its Science
PANXEON detects stage 1-2 pancreatic cancer with 87% sensitivity, but FDA's companion diagnostic pathway may be the bigger obstacle...