Covariate-adaptive randomization represents an advanced methodology in the design of clinical trials, ensuring a balanced distribution of prognostic factors among treatment groups. This approach ...

INDIANAPOLIS, Jan. 12, 2023 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing ...

A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...

Obexelimab met the primary endpoint demonstrating a clinically meaningful and highly statistically significant 56% reduction in risk of IgG4-RD ...

Enrollment on track in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis IND application for Descartes-08 in myositis accepted by FDA; seamless adaptive clinical trial offering potential ...