Intrinsic Imaging Awarded Phase II Cancer Trial
Intrinsic Imaging announced that it has been awarded an international Phase II clinical trial to assess a new treatment for patients with advanced squamous cell carcinoma (SCC). Intrinsic Imaging will provide comprehensive imaging core lab services including, but not limited to, protocol and imaging charter development, site qualification, site training and management, image transfer, blinding and processing of images acquired by computed tomography (CT) or magnetic resonance imaging (MRI). Subsequently, study treatment response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) evaluation criteria. According to ClinicalTrials.gov, there are currently nine Phase II clinical trials listed for SCC.
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.
