Risk-based quality management requires linking quality plans to data management protocols. EU regulators now expect documented traceability between RBQM...

Coya Therapeutics enrolls 100th patient in ALSTARS trial of COYA 302 for ALS, reaching a key recruitment milestone for...

BH-30643 achieves 45% response rate in osimertinib-resistant NSCLC patients with C797S mutations, showing 88% disease control in Phase 1/2...

Summit Therapeutics presents updated overall survival results for ivonescimab in EGFR-mutated NSCLC from the Phase III HARMONi trial.

Roche's Lunsumio combo met its primary endpoint in Phase III follicular lymphoma trial, beating rituximab plus lenalidomide on progression-free...

Dr. Olga Kubassova, Founder and CEO of Image Analysis Group (IAG), discusses how AI-driven imaging biomarkers extend the value...

The Lancet calls out "hard to reach" as a stigmatizing label. For clinical ops, it's a site selection failure...

Med-Gemini scores 91% on MedQA. OpenAI's o1-preview hits 96%. Neither number tells you what happens when the algorithm meets...

Mednet AI intake tool automates EHR-to-EDC data entry in clinical trials, reducing manual transcription and entry errors for research...

Hinge Bio runs its Phase I trial on a single Medrio platform, consolidating EDC, ePRO, and RTSM to reduce...