Applied Clinical Trials Digital Edition - November 2009
GLOBAL TRIALS : South Africa?s Positioning Fosters Healthy Trial Landscape Croatia?s Dynamic Qualities CROs Must Manage Italy?s Regulatory Makeover EDC?s Evolution in Japan Also in this issue : Postmarketing Pushes Back Approvals, EU Regulators Increase Involvement, Site Shake-Out Benefits Those That Remain, Is in Silico Modeling the Economic Solution?
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.
