The National Institute for Health Research Bristol Biomedical Research Centre at the University of Bristol has selected Signant Health as its partner to provide electronic informed consent support for an oncology trial. The partnership will see Signant Health collect direct feedback from patients and sites on the impact of its TrialConsent platform during a prostate cancer study. The research seeks to understand how eConsent can improve patient comprehension and reduce site burden as well as to identify areas of opportunities and challenges for future clinical trials.
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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.