Catalent Completes Expansion at Singapore Clinical Supply Facility

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.

In 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.

How digital intake solutions driven by technological advancements can help overcome the challenges of operating across different regulatory markets.

One-year results from the Pavilion study showed patients who received Susvimo (ranibizumab) refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale.

Data from the FIBRONEER-IPF and FIBRONEER-ILD studies, published in The New England Journal of Medicine, highlight nerandomilast’s potential as a first-in-class PDE4B inhibitor for idiopathic and progressive pulmonary fibrosis, demonstrating efficacy as monotherapy or with existing antifibrotics.