UK Regulator Cites CluePoints’ Solutions In Updated Guidance
CluePoints has been cited in the updated Good Clinical Practice (GCP) guidance from the UK’s MHRA, putting the agency´s weight behind CluePoints’ statistical monitoring solutions.
The document, Oversight and Monitoring Activities, covers a broad range of clinical trial activities, including the use of committees to manage trials or review emerging safety data, the central review of clinical trial data, data management processes, and pharmacovigilance signal detection.
Read more about the updated guidance 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.
