Verantos Receives FDA Support to Demonstrate Advanced Approaches to RWE
Verantos announced that it has received a grant award from the U.S. Food and Drug Administration to implement a multi-year advanced real-world evidence (RWE) study.
The program, "Transforming Real-World Evidence with Unstructured and Structured Data to Advance Tailored Therapy" (TRUST), was sponsored by the FDA Center for Drug Evaluation and Research.
As RWE is increasingly used to make clinical assertions and refine the standard of care, rigorous approaches are required to meet evidentiary standards. This three-year study will apply advanced RWE to a clinical scenario, and data quality will be studied by comparing traditional approaches to advanced approaches. The study, FD-20-030, includes innovations in deep phenotyping, data linkage, and phenotype accuracy measurement.
For more information, click here.
Realtime Electronic Data Capture at Investigator Sites: Laboratory Data and Beyond
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.
