Clinical Prediction Models Are Breaking Trials and Nobody Is Requiring a Fix
Only 12% of ~4,000 clinical prediction model studies share code, per Nature Medicine. FDA and NIH mandates exist, but...
eCOA Integration With EDC Critical for CNS Trial Database Lock
eCOA Integration With EDC is critical for CNS trials: disconnected systems trigger weeks of reconciliation work at database lock.
AI-Driven Automation Reduces EDC Query Volume as Trial Complexity Grows
AI-driven automation reduces EDC query volume as trial complexity grows, collapsing configuration time from days to minutes across clinical...
$3.4M Grant Studies Menopause Link to Alzheimer’s Risk in Women
A $3.4M grant funds research into how perimenopause hormonal changes may increase Alzheimer's risk in women, who face double...
$28.6M ARPA-H grant funds protein aggregation dataset for neurodegenerative disease prediction
ARPA-H grants $28.6M to build the largest protein aggregation dataset ever attempted, with 10 billion measurements to predict neurodegenerative...
Phase III trial of cadonilimab begins in perioperative colon cancer
Phase III trial of cadonilimab begins in perioperative colon cancer, testing dual PD-1/CTLA-4 blockade in MSI-H/dMMR patients seeking pathological...
The EU Just Made Pre-Submission Advice Permanent. Your CTA Strategy Is Now Out of Date.
EMA's ACT EU advice pilot becomes permanent in January 2027, giving EU sponsors consolidated multi-country feedback before CTA submission....
Clinical Data Teams Shift Focus to AI Validation and Human Oversight
Clinical data teams now prioritize AI validation and human oversight in regulatory workflows, following FDA guidance on predetermined change...
Patient-Owned Health Data Model Reduces Clinical Trial Recruitment Redundancy
Patient-owned health data model reduces clinical trial recruitment redundancy by enabling persistent consent and longitudinal data sharing across studies.
Sionna Advances SION-451/SION-2222 Combo Based on SION-719 Analysis
Sionna advances SION-451/SION-2222 combo into Phase 2a trial for cystic fibrosis, building on insights from prior SION-719 analysis.