Podcast Series- eCTD
eCTD: Learn from Early Adopters
Implementation of the electronic Common Technical Document or eCTD is still early on the adoption curve within the pharmaceutical industry. Regulatory professionals will be interested to hear the insights from participants of an eCTD Early Adopters Roundtable sponsored by Applied Clinical Trials and Clarkston Consulting.
Get Comfortable Moving from Paper to Electronic
Quintiles’ Laurie Henricks tells us how-in her CRO capacity-she coaches sponsor/clients to get more comfortable with moving from paper submissions to electronic submissions.
Challenges to eCTD
Janel Firestein, our roundtable moderator, offers her take on the expert discussion and the major challenge she sees to eCTD implementation.
Bringing in an Objective Outsider
Michael J. McGraw, PharmD, MS, regulatory affairs manager at Teva Neuroscience, discusses the benefits of bringing in an objective outsider.
Training Employees on eCTD
Shire Pharmaceuticals’ Carol Rutkowski, Senior Director, Global Regulatory Operations, Shire explains the benefits of training employees in regard to the regulatory eCTD submissions world.
Pilot Testing eCTD Software
Veteran regulatory affairs professional Dr. Albert Edwards, PharmD, RAC, Director, Regulatory Operations, Takeda offers his views for eCTD implementation in the future
Related Links
eSubs and eCTD and RPA, Oh My!
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.
