Applied Clinical Trials Digital Edition - October 2010
REGULATORY : Is It Safe to Outsource Safety? Waiving Inclusion/Exclusion Criteria CRO/SPONSOR : Metrics - The Pitfalls of Over Collection SUBJECT RECRUITMENT : Trial Results Provided to Volunteers in Pilot Program Also in this issue : New Reform Law Requires Fee Disclosure, GCP Standards in Global Trials, A Learning Healthcare System, The Physician Payments Sunshine Act
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.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
May 20th 2025Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.
