Applied Clinical Trials Digital Edition - August 2009
EDC : Getting it Right - EDC Rescue Studies INFORMATION TECHNOLOGY : How Health Intelligence Leads to Smarter Research CRO/SPONSOR : The Proactive Advantage in Risk Management Also in this issue : All Eyes on R&D as U.S. Talks Health Care, Fragmented System Stifling EU Research, IT Convergence: Are We There Yet?, Why Virtual Meetings Make Sense
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.
Oveporexton Shows Superior Efficacy in Phase II Narcolepsy Type 1 Trial Without Hepatotoxicity
May 16th 2025In the TAK-861-2001 Phase IIb study, oveporexton significantly improved wakefulness, daytime sleepiness, and cataplexy frequency in patients with narcolepsy type 1, outperforming current therapies and avoiding liver toxicity seen with earlier OX2R agonists, according to results published in The New England Journal of Medicine.
