Applied Clinical Trials Digital Edition - July 2010
SITES : Incorporating Standard of Care in Study Budgets Benefits of CTMS at the Investigative Site Also in this issue : FDA Transparency Efforts to Impact Research, Survey Assesses Europe?s Clinical Trials Directive, Tapping into the Potential of Pharmacists, Biosimilars Make Headway in the U.S.
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
AbbVie Submits sNDA to FDA for Venclexta-Acalabrutinib Combo in Frontline CLL
July 29th 2025The application is backed by Phase III AMPLIFY trial results showing the oral combination significantly improved progression-free survival versus chemoimmunotherapy in previously untreated chronic lymphocytic leukemia.
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.
J&J Submits sBLA to FDA for Tremfya Label Expansion Based on PsA Joint Damage Inhibition Data
July 29th 2025The submission is supported by Phase IIIb APEX trial results showing Tremfya reduced symptoms and inhibited structural progression in biologic-naïve patients with active psoriatic arthritis.
