The FDA Just Rewired Alzheimer’s Trial Design, Most Sponsors Haven’t Caught Up Yet
FDA's approval of two blood-based Alzheimer's tests signals regulators now accept plasma biomarkers as primary endpoints, reshaping CNS trial...
RBQM’s Full Value Exceeds Current Financial Models, Tufts-CluePoints Analysis Shows
RBQM's full value exceeds current financial models, with omitted factors like rework reduction and inspection readiness potentially representing more...
Advarra identifies five workflow patterns causing clinical trial activation delays
Advarra identifies five workflow patterns causing clinical trial activation delays, from duplicate data entry to poor visibility of prerequisites.
Vanda’s VQW-765 Fails Primary Endpoint in Phase III Social Anxiety Trial
Vanda Pharmaceuticals' VQW-765 fails primary endpoint in Phase III social anxiety trial, showing no statistically significant benefit over placebo.
Entrada Therapeutics Reports Phase 1/2 Data for ENTR-601-45 in DMD Exon 45 Skipping
Entrada Therapeutics reports Phase 1/2 data for ENTR-601-45 in exon 45 skipping, the most common single-exon target affecting 8%...
One Medicine, One Payment: How Boehringer Ingelheim Is Closing the Loop on Site Payments
After consolidating 40 systems into one platform, Boehringer Ingelheim's Sarita Thomas explains why site payments was the missing piece...
The Study Build That Used to Take Weeks Now Takes Minutes
Inside Crucial Data Solutions' Floyd AI and the case for synthetic control arms
20 Hours Back Per Activation: What WCG’s New Tool Reveals About the Real Cost of Manual Study Startup
WCG's Activation Intelligence saves 20+ hours per study activation. Here's what that number means for site startup budgets and...
Proteomic Aging Clocks Enter Clinical Trials: What Sponsors Need to Know Before the FDA Does
Proteomic aging clocks are moving into clinical trials, but FDA surrogate endpoint standards and assay reproducibility gaps could stall...
Phase IV heart failure studies use digital tools to address patient dropout from low perceived benefit
Heart failure Phase IV studies use digital tools and remote monitoring to reduce patient dropout when perceived personal benefit...