Pivotal has announced that it will provide specialized clinical research services in a clinical trial to study the efficacy and safety of hyperimmune plasma in the treatment of hospitalized patients with COVID-19. The two-phase study is a multicenter, randomized, sequential and adaptive design clinical trial that will use the plasma extracted from about 200 convalescent patients with COVID-19 to treat patients in the acute phase of this disease, compared with standard treatment.
For more information on the study, click here.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.