Advarra has announced the launch of the Advarra Site-Sponsor Consortium. This collaboration, beginning with over 20 research sites, life sciences companies, standards bodies, and industry organizations, aims to connect site and sponsor technology, addressing key inefficiencies currently experienced across the clinical research ecosystem. The consortium membership will continue to expand over time to ensure this effort mirrors the diverse makeup of the clinical research ecosystem.
Read more about the new consortium here.
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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.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.