GlaxoSmithKline to Implement Medidata Designer
Medidata Solutions announced that GlaxoSmithKline (GSK) has decided to implement Medidata Designer, a study design optimization solution, for its Clinical Research and Development organization. Using Designer, GSK can consistently design studies that meet key objectives and collect necessary data in a streamlined and efficient manner.
Medidata Designer drives study design quality with a CDISC-compliant data model that enforces the links across objectives, end points and procedures. This reusable metadata accelerates system setup, such as electronic data capture build, and automates the derivation of protocols and other key clinical deliverables. It improves compliance with standards, allows clinicians to focus on the science of clinical research and not on document management, and speeds study starts, shortening time to market for new therapies.
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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
