FDA Signs CRADA with CluePoints
The FDA has signed a Cooperative Research and Development Agreement (CRADA) with CluePoints for its Central Statistical Monitoring solution.
The FDA has signed a Cooperative Research and Development Agreement (CRADA) with CluePoints for its Central Statistical Monitoring solution to explore a data driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness.
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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.
Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor
July 9th 2025In final data from the Phase III ENLIVEN study, Turalio (pexidartinib) demonstrated durable tumor responses and a consistent safety profile in patients with symptomatic TGCT not amenable to surgery.
