endpoint and Berlinger to Provide Visibility of Historical Temperature Journey of an IMP
endpoint Clinical and Berlinger & Co. AG have announced their partnership to provide complete end to end visibility of the entire temperature history of an Investigational Medicinal Product (IMP).
Our organizations understand the risks of managing temperature-controlled IMP, and therefore, we focused on designing a solution that aims to help reduce risk and eliminate the core issues. Such problems include limited transparency and missing information, the lack of immediate centralized visibility, time-consuming excursion management and slow decision making, time-consuming data consolidation for audits, wastage of drugs, and patient rescheduling or lost.
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.
