Vitalograph Launches New In2itive e-Diary
The new In2itivee-Diary is a handheld medical device with touchscreen for eCOA data gathering. Using Vitalograph’s Fleisch Pneumotachograph flowhead, it provides accurate measurement of respiratory endpoints in clinic or for home monitoring.
Features include integrated training modules provide technique reminders supporting compliance and data quality, alerts and workflows are fully customizable to fit study protocols, and much more. The In2itive e-Diary is a fully validated class II (USA) / IIa (EU) medical device, meeting or exceeding all technical requirements for cyber-security and data protection.
Read more in 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.
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.
