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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.