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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
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.
