Montrium Announces Re-Engineered eTMF Connect

Results from a retrospective study found that Amtagvi (lifileucel) achieved a 48.8% objective response rate in patients with advanced melanoma who had previously received immune checkpoint inhibitors.

In 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.

Results from the Phase III CAHtalyst show that patients treated with Crenessity for classic congenital adrenal hyperplasia achieved and maintained lower, more physiologic glucocorticoid doses while keeping key adrenal biomarkers at or below baseline levels.

Why a fundamental reimagining of how clinical studies operate is still necessary to achieve a true paradigm shift—and shed the cycle of reliance on incremental gains.

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.