Unblinded: A Clinical Trial Podcast

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.

Jim Reilly, Veeva's VP of Development Cloud Strategy, joins Richard Young to discuss their takeaways from Veeva's recent North American R&D and Quality Summit. They talk about patient centricity, the future of digital trials, and major updates from Veeva announced at the event.

In this discussion, Andy Cooper, CEO of CluePoints and a veteran in clinical data analytics, tackles the misconceptions surrounding AI in clinical trials. He explains the essential differences between supervised and unsupervised machine learning, emphasizing the need for domain-specific models. Andy highlights the potential of AI to predict site issues and streamline operations by reducing manual tasks. He also addresses concerns about data privacy and trust in AI tools, advocating for consistent results over transparency to build confidence in machine learning.

This week, Richard Young speaks to Tim Davis, vice president of strategy for MyVeeva for Patients. In recent years, decentralized clinical trials, patient centricity, and site centricity have become buzzwords for sponsors and CROs. This episode covers how to cut through the hype and focus on ideas that would both impact patient lives and make things easier for sites. As Tim explains, positive change starts with expanding patient choice during clinical trials. 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 Guest: Rhona O’Donnell, VP, Data Management Systems and Standards, Novo Nordisk This week, Richard Young is joined by Rhona O’Donnell, VP, Data Management Systems and Standards at Novo Nordisk. They discuss the evolution of the data management role, and how we can prepare for the future through collaboration and more effective training for the next generation. Richard and Rhona share their thoughts on the growing list of responsibilities facing data managers; why risk-based data management can help make trials more sustainable; the largest opportunities for time savings within the data management world; and the big initiatives that Novo Nordisk is working on to improve their data management processes.  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