Sponsors Should Match Outsourcing Model to Development Strategy, Not Vice Versa
Sponsors must align outsourcing model to development strategy, not vice versa, as new regulatory pathways require faster adaptation.
AI Adoption in Clinical Trials Hindered by Validation, Governance Gaps
AI adoption in clinical trials faces validation and governance gaps, not technical doubts. Organizations need process infrastructure and proper...
Tegoprazan Meets Primary Endpoint in Phase 3 NERD Trial
Tegoprazan Phase 3 NERD trial met primary endpoint, showing 74% relative increase in heartburn-free days over placebo at 100...
Advarra funds PRIM&R AI ethics curriculum for research oversight
Advarra funds PRIM&R AI ethics curriculum for research oversight. IRBs gain guidance on algorithm governance and AI tool evaluation...
Neurology Trial Sites Take 167 Days to Activate, Delaying Enrollment
Neurology trial sites take 167 days to activate on average, causing enrollment delays and pushing Phase III programs millions...
Joint Commission Awards UPMC for Genomic Surveillance Program
Joint Commission awards UPMC's Genomic Surveillance Program for detecting hospital bacterial transmission events missed by conventional infection surveillance m
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...