Unblinded: A Clinical Trial Podcast

Demetris Zambas, Global Head of Data Monitoring and Management at Pfizer, has over three decades of experience in life sciences. He shares his journey from vaccine motivation to pivotal roles in data management and clinical trials. The discussion highlights the evolution of data science, AI’s role as a supportive tool, and whether striving for data perfection is necessary or if fit-for-purpose quality suffices. Demetris advocates for balancing quality, speed, and cost, emphasizing the importance of collaboration and continuous improvement in the industry.

Nicole Raleigh hosts this special episode on-site from Boehringer Ingelheim’s Human Pharmacology Center in Biberach, Germany. Andrea Kloeble and Daniel Schwenk are part of the team reimagining drug development at Boehringer Ingelheim through the One Medicine Platform. They explain how their organization strives for medical excellence, and why exponential growth in study data volumes and sources requires a connected technology ecosystem. And Richard is in the guest seat this week to put this transformative initiative into industry context: as he explains, life sciences is no longer willing to accept single-use data.

We can think of no better way to kick off Season 3. In a deeply personal and moving episode, two patient advocates share their stories of working tirelessly to deliver a safe and effective gene therapy for children suffering from spastic paraplegia 50 (SPG50). After his infant son received a diagnosis of this ultrarare neurodegenerative disease in 2017, Terry Pirovolakis began a daunting four-year journey to find a breakthrough treatment that would help Michael and other affected children. We also hear from Samuela Bellini, who wants to bring this therapy to children in Italy. Their achievements, and reflections, are an inspiration for our industry. Subscribe to State of Digital Clinical Trials, a Veeva podcast, to get new episodes as soon as they are released.

This week, Richard Young speaks to Ken Getz, executive director and research professor at Tufts Center for the Study of Drug Development. Already well-known in our industry for his pioneering research on protocol design complexity and trial efficiency, Ken’s most recent study found that the average number of amendments per protocol increased by almost 60% over the past seven years. In this episode, Richard and Ken debate whether clinical research is striking the right balance in its approach to risk and innovation, the problem-solving role played by sites, and CISCRP’s work to improve public trust in scientific advances. Subscribe to State of Digital Clinical Trials, a Veeva podcast, to get new episodes as soon as they are released.

Terttu Haring and Leonie Christianson from Syneos Health share their expertise in patient-centered clinical strategies and data management. They discuss the importance of putting patients back at the heart of clinical trials amidst the growing influx of data and technology. Their conversation covers the shift towards decentralized clinical trials, the collaboration needed between data managers and clinicians, and the need for ethical, patient-centric approaches in leveraging clinical data for improved outcomes. Tune in for insights on transforming clinical research!

The first episode of Season 2 is now out! This week, Richard Young speaks to Helen Shaw, co-founder and director of clinical operations at VCTC (a virtual site) and Marie-Claire Flavin, who joined Veeva after many years conducting clinical research for the NHS. Digital trials sometimes have a seesaw effect on different users: more flexibility for patients can mean a heavier admin burden for sites. But it doesn’t have to be this way. This episode covers novel ways that sites are using technology to expand patient choice in clinical research without compromising operational efficiency. Get in touch with us if you would like to contribute to the podcast or share your feedback SDCTpod@veeva.com Subscribe to State of Digital Clinical Trials, a Veeva podcast, to get new episodes as soon as they are released. Spotify: https://lnkd.in/e5pJ7saP Youtube: https://bit.ly/3quY9FY Apple Podcasts: https://lnkd.in/efMTxybk Host: Richard Young, VP, Strategy, Veeva Vault CDMS Guests: Helen Shaw, Co-Founder and Managing Director, VCTC Marie-Claire Flavin, Director, Customer Success, Veeva Site Solutions (EMEA)

In this week’s episode, Richard Young speaks to Vivienne van de Walle, medical director and founder of PT&R (an independent research site in the Netherlands), and Bree Burks, who joined @Veeva from a clinical research background where she supported nearly 1,000 trials across different roles. Sites have been voicing their concerns for years about how the industry runs clinical studies. In this episode, Vivienne and Bree explain the tangible ways that sites (and patients) are hurt by inconsistent technology and the steps to make it better. Get in touch with us if you would like to contribute to the podcast or share your feedback SDCTpod@veeva.com Subscribe to State of Digital Clinical Trials, a Veeva podcast, to get new episodes as soon as they are released.

Exploring the evolution of clinical operations from paper to digital era, Emma Earl shares insights on career advancements in the tech-driven pharmaceutical industry. Highlighting the importance of efficient systems and data management, the podcast delves into the benefits of transitioning to CTMS and balancing scientific research with operational needs.

Chris Moore, President of Veeva Europe, shares his insights on the evolving landscape of clinical trials in the U.K. and Europe. He discusses the recent government efforts to revitalize the U.K. life sciences sector, detailing the impact of Brexit and COVID-19. Moore emphasizes the need for improved technology in clinical trial processes, addressing challenges like data fragmentation. He also explores the European Commission's initiatives for a unified medicines market and the potential of AI to enhance efficiency and access in healthcare.

Patrick Nadolny, Global Head of Clinical Data Management at Sanofi, discusses the future of EDC, new programs at Sanofi, and the need for a patient-driven trial model. They explore the evolving landscape of clinical data management, the impact and challenges of data management in clinical trials, and the importance of simplifying processes and partnering with technology providers for solutions. They also emphasize the need for continued experimentation and rethinking strategies in clinical data innovation.