Senn Framework Targets Protocol-Specific Content for Live Site Initiation Visits
Live site initiation visits should focus on protocol-specific content that creates operational risk, per Christine Senn's framework for SIV...
Seismic Pharmaceuticals Enrolls First Patient in Phase 3 Trial of Istaroxime for Cardiogenic Shock
Seismic Pharmaceuticals enrolls first patient in Phase 3 trial of istaroxime for cardiogenic shock, the only late-stage program targeting...
Insilico Medicine Begins Phase III Trial of AI-Discovered Drug Rentosertib for IPF
Rentosertib becomes first AI-discovered drug in Phase III trial for IPF, testing lung-function decline over 52 weeks across 47...
Tyra Selects 60mg Dose of Dabogratinib in NMIBC Phase 2 Study
Tyra Biosciences selects 60mg dose of dabogratinib in NMIBC Phase 2 Study, advancing oral FGFR3 inhibitor development for bladder...
FDA Grants Priority Review to Roche’s Enspryng for MOGAD
FDA grants Priority Review to Roche's Enspryng for MOGAD after Phase III trial showed 68% reduction in relapse risk...
DYNAMIKA™: The Operating System for Imaging Clinical Trials
Sponsored by Image Analysis Group. Why the imaging platform decision is the single most consequential infrastructure choice a sponsor...
A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue
CONSONANCE's digitally enhanced MS endpoint cut required sample size 24.9%. Here's what that number costs in protocol amendments, IRB...
Proteomic Aging Clocks Just Changed What a Phase 2a Trial Has to Prove
A Nature Biotechnology phase 2a trial ran six proteomic aging clocks simultaneously, here's what that means for biomarker strategy...
Advarra Releases IRB Reportable Events Checklist to Reduce Over-Reporting
Advarra releases IRB reportable events checklist to help research teams distinguish critical safety signals from minor deviations requiring prompt...
Nektar to Release 24-Week Off-Treatment Data for Rezpegaldesleukin in Alopecia Areata
Nektar will release 24-week off-treatment data for rezpegaldesleukin in alopecia areata, testing durability after dosing ends in the Phase...