A top five CRO has signed a Master Services Agreement (MSA) with NewCardio, reports the Santa Clara, CA-based cardiac diagnostic and services company. The agreement gives the unspecified CRO a license to use NewCardio's QTinno software, which, according to the company's Web site, "provides fully automated and comprehensive analysis of QT intervals and other ECG markers for cardiac safety assessment in drug development."
"The adoption of QTinno by the clinical pharmacology units at this top five CRO will enable them to deliver quality TQT/QT studies with higher accuracy and lower intrinsic variability in a timely and cost-effective manner," says Vincent Renz, NewCardio's President and Chief Operating Officer, in a company press release.
By adding this software to its existing offerings, the CRO will also be able to "capture additional" revenue because it will be able to provide customers with more services, the press release reports.
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.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.