Applied Clinical Trials Digital Edition - May 2011
eCLINICAL : Paperless IRB - Streamlined Efficiency Translating Data into Meaningful Metrics STATISTICS : Review of Categorical Data Analysis LABS : Industry Perspective of Good Clinical Laboratory Practice Also in this issue : Pharmaceutical R&D Funding, Europe 2020 Strategy, Protocol Amendments, Predicting Adverse Events
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.
