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!
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
