CTTI Takes on Site Investigator Turnover in New Recommendations
The Clinical Trials Transformation Initiative announced at the Society for Clinical Research Sites Global Site Solutions Summit, new recommendations aimed at reducing high rates of turnover among U.S. clinical trial site investigators and broadening the pool of qualified investigators. The guidelines offer practical actions that sites, sponsors, CROs, and health systems can take to support continuous training, maintain clear communications and operational procedures, and foster a climate of mutual respect. Read the full release 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.
