eCTD: Moving from Paper to Electronic
Hear from Quintiles' senior director of global regulatory affairs and medical writing on moving from a paper to electronic submission.
eCTD -Podcast: Get Comfortable Moving from Paper to Electronic Quintiles
Laurie Henricks (Senior Director, Global Regulatory Affairs and Medical Writing, Quintiles) tells us how--in her CRO capacity--she coaches sponsor/clients to get more comfortable with moving from paper submissions to electronic submissions.
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.
