CDISC Selects Nextrials as a Registered Solutions Provider
Nextrials, Inc. has been approved by the Clinical Data Interchange Standards Consortium (CDISC) as one of 15 registered solutions providers, and is the only company offering an electronic data capture (EDC) product supporting the CDISC Healthcare Link Initiative. Begun in 2005, the CDISC Healthcare Link Initiative focuses on the interoperability of electronic health records (EHR) platforms with EDC technology for clinical trials.
Nextrials’ Prism™, an EDC and clinical trial management platform, supports CDISC standards. The platform also has been used in a multi-site study where live patient data was collected and shared by what had previously been two disparate data management platforms.
“By using a standards-based process, workflow for clinical research can be integrated into the workflow for clinical care. This streamlines the process for sharing clinical care information for multiple uses including research and public health. It promotes a reduction in time for data entry and increased data accuracy by eliminating transcription," commented Rebecca Kush, CDISC president and CEO.
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.
