Applied Clinical Trials Digital Edition - May 2010
DATA INTEGRATION : Universal Data Standards - Are We Almost There Yet? Beyond the Final eFrontier When EDC and EHR Converge Also in this issue : How Washington?s Health Reform Impacts Pharma, Efforts to Reach Consensus on ePRO in the EU, An Intimate Look at the Trial Volunteer Experience, Braving the World of Social Media
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.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
