TD2 and Medidata Partner in ClinOps
Medidata, a Dassault Systèmes company, has announced that Translational Drug Development (TD2), a precision oncology contract research organization, has signed an agreement to adopt Medidata’s Rave CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File) solutions, offerings within Medidata’s Unified Platform.
Rave CTMS aims to address struggles that study teams experience in trying to manage and oversee clinical trials due to the fragmented and rapidly changing trial ecosystem. In 2021, Medidata released enhancements to Rave CTMS including ad hoc reporting and proactive risk management support.
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.
