ERT Delivers Insights to Identify COVID-related Trial Risks
ERT has announced new reporting capabilities that help clinical trial sponsors and CROs ensure data collection during current global stay-home mandates. The Dashboard integrates data on coronavirus infection rates in geographic areas surrounding study investigative sites, so sponsors can identify and intervene where patient and site compliance to study protocols may be at risk.
For more information, 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.
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.
