CRO/SPONSOR : Personalized Medicine Development - Role of CROs TRIAL DESIGN : Eye Movements Help Determine Side Effect Profiles SUBJECT RECRUITMENT : Connecting Type 2 Diabetics to Clinical Trials INFORMATION TECHNOLOGY : Cloud Computing Brings Efficiencies to Life Sciences Also in this issue : Biosimilars Development, Funding in Europe, Transforming R&D, Subject Protection in India
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.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.