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.

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In this episode, Richard Young speaks with Terttu Haring and Leonie Christianson from Syneos Health. Nowadays, clinical data managers have the tools to collect novel insights from large volumes of data. But has this influx of data and tech caused us to move farther away from the patients we serve?

Together Terttu, Leonie, and Richard outline the major opportunities for life sciences organizations to put patients back at the heart of clinical strategy.

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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

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This week, Richard Young speaks to Alan Morgan, CEO Advisor of Excelya. In recent years, sponsors and CROs have invested heavily in “big data” tools for site selection and productivity. But, has that investment paid off? Richard and Alan discuss whether we’ve come any closer to truly patient-centric trials – and what we still have left to do. From partnering with patient advocacy groups to going back to the basics on data management, this episode covers some new industry initiatives that could make a positive difference for patients.

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Host: Richard Young, VP, Strategy, Veeva Vault CDMS

Guest: Luis E. Torres, Head of Clinical Programming FSPx, Labcorp

This week, Richard Young speaks to Luis E. Torres, head of Clinical Programming FSPx at LabCorp. They discuss how data managers can prepare for the future of clinical trials by adopting new technologies and skills to keep decentralized clinical teams connected. Richard and Luis share their thoughts on designing studies and processes that support end-user needs; the shifting goal posts of data cleanliness and database build expectations; and why data managers are uniquely positioned to solve the “Rubik’s Cube” of challenges involving people, processes, and technology.

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Host: Richard Young, VP, Strategy, Veeva Vault CDMS

Guest: Mayank Anand, VP and Global Head of Data Strategy and Management, GSK

In this week’s conversation, Richard Young and Mayank Anand, global head of data strategy and management at GSK and Chair of SCDM, discuss how clinical data professionals’ roles are evolving in a world of decentralized data. It’s a great time to be a clinical data professional, they agree, as a once invisible role moves front and center to optimize trial protocols, operations, and results, and speed patient access to better treatments. SCDM offers professionals a global voice and a forum for discussion and debate, and Mayank summarizes the organization’s key goals. Both Richard and Mayank share insights into understanding end user and patient needs; balancing the needs of different stakeholders; and solving a Rubik’s cube of challenges that involve people, processes, and technology. Mayank also shows how new perspectives are driving a more inclusive strategy and collaborative mindset that is already improving patient focus and business results at GSK and within the industry.

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Host: Richard Young, VP, Strategy, Veeva Vault CDMS

Guest: Natalie Townsend, VP, Strategy, Veeva RTSM

This week, Richard Young speaks to Natalie Townsend, the global lead for Randomization and Trial Supply Management (RTSM) strategy at Veeva. They discuss the evolution of ‘digital’ clinical trials from the early days of phone-based and spreadsheet-centered activities to the role technology is playing today. Will data management clash, combine, or sit comfortably with the world of site supplies and randomization? And how can technology help with challenges faced by both sides?

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Host: Richard Young, Vice President, Vault CDMS Strategy, Veeva

Guest: Trevor Griffiths, Senior Director, Clinical Data Management, Syneos Health

Description: Host Richard Young speaks to Trevor Griffiths, senior director for clinical data management at Syneos Health. Data management is becoming much more complex for CROs, as trials become larger and data sources more diverse. Yet Syneos was still able to eliminate 3,000 hours of manual review in a single trial through machine learning. As the industry moves to a single view of all clinical study data, will we get clean data ready faster? What does this mean for the role of the data manager? *Veeva CDB refers to Veeva’s clinical data platform for complete and concurrent data (available late 2022).

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Host: Richard Young, Vice President, Vault CDMS Strategy, Veeva

Guest: Doug Bain, Chief Technology Officer, KCR

Host Richard Young speaks to Doug Bain, chief technology officer at KCR, a contract research organization (CRO). They discuss the role of electronic data capture (EDC) in today’s complex, dynamic clinical trial landscape. With only a fraction of trial data coming from EDC, are its days numbered? And what are some of the tangible opportunities made possible by digital clinical trials that could ease the burden on sites and patients?

Subscribe to State of Digital Clinical Trials, a Veeva podcast to get new episodes as soon as they are released.

Subscribe to State of Digital Clinical Trials, a Veeva podcast, on Apple (https://go.veeva.com/podcast-digital-...),Spotify (https://go.veeva.com/veeva-digital-tr...), and Youtube ( ) to get new episodes as soon as they are released.

Host: Richard Young, Vice President, Vault CDMS Strategy, Veeva Systems

Guest: Tanya du Plessis (Chief Data Strategist and Solutions Officer, Bioforum the Data Masters)

Description: Host Richard Young speaks to Tanya du Plessis, chief data strategist and solutions officer at Bioforum the Data Masters, a data-focused CRO. The old days of linear trial processes and pushing paper are thankfully over, presenting exciting opportunities in clinical data management. In fact, data managers are moving from behind the scenes to center stage as regulations change. So what do data managers need in their toolkit if they are to be effective? And are we closer to making patient-centric trials a reality?

After more than two years apart, European life sciences came together in Zurich in June. There are big advances underway that will make clinical research faster, better connected, and more patient-centric. But there’s also frustration at the silo-driven approach. @Richard Young recaps what’s on the minds of life sciences leaders with Chris Moore, President, Veeva Europe.

If you weren’t able to join us in Zurich, watch highlights at https://www.veeva.com/eu/events/rd-summit/on-demand-overview/

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.

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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.

In this episode, Richard Young speaks with Bayer’s Head of Clinical Trial Management Services and Solutions, Emma Earl. With over 20 years of experience, Emma is perfectly positioned to comment on the rapid transformation in clinical operations and what changes are coming up on the horizon. Together they outline the major opportunities and the missing ingredients for delivering efficient and patient-centric 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.

Host: Nicole Raleigh, Web Editor, Pharmaphorum

Guest: Chris Moore, President, Veeva Europe

We have a special episode for you this week! In a twist to our usual format, Nicole Raleigh of Pharmaphorum is in the host seat interviewing Veeva’s Chris Moore about his outlook on clinical trials in the U.K. and Europe. In a wide-ranging conversation, they cover the recent report from Lord O’Shaughnessy on U.K. life sciences, the impact of EU CTR, the potential and pitfalls of artificial intelligence, and what R&D organizations need next.

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.

Host: Richard Young, Vice President of Strategy, Veeva Vault CDMS

Guest: Patrick Nadolny, Global Head of Clinical Data Management, Sanofi

This week, Richard Young speaks to Patrick Nadolny, global head of clinical data management, Sanofi. In recent years, there’s been an explosion of new data from non-EDC sources like ePRO, imaging, and telemedecine. But, what does that mean for traditional EDC? In this episode, Richard and Patrick discuss the future of EDC – and whether we should retire the term all together. Plus, Patrick discusses new programs at Sanofi including what he calls “EDC-less” trials and a new “Act for Patients” initiative.

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.

Host: Richard Young, VP, Strategy, Veeva Vault CDMS

Guest: Jim Reilly, VP, Development Cloud Strategy, Veeva

This week, Richard Young is joined by Jim Reilly, Veeva’s VP of Development Cloud Strategy. They discuss learnings from Veeva’s recent North American R&D and Quality Summit — including observations and trends from hundreds of biopharmas. Tune in to hear their takeaways on patient centricity, the future of digital trials, and major updates from Veeva announced at the event. 

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Veeva website: https://go.veeva.com/l/28972/2023-08-22/9p7245

Does ChatGPT understand clinical trials? This week, Richard Young speaks to Andy Cooper, CEO of CluePoints, about going beyond the buzzword and making AI a reality in clinical data management. They discuss how to approach these technologies today and how to identify the areas of clinical trials where AI will be the most useful. Andy also deep dives on the different types of machine learning, how to train and develop trust with these tools, and why industry context is key when using AI-powered tools. 

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.

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Veeva website: https://go.veeva.com/l/28972/2023-08-22/9p7245

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.

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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.

Pfizer’s Vice President for Data Monitoring and Management Demetris Zambas joins Richard in the hot seat and shares his fascinating journey through life sciences: from how his childhood experiences of receiving vaccines shaped his values to his contributions to our industry’s leading companies, and everything in between.

They discuss the evolution of data science, the potential applications of AI, and whether we still need to strive for data perfection. Although the tools have changed, the mission and successful traits of a strong data scientist remain consistent — and could soon be enhanced by an AI assistant.

This discussion reflects the views and opinions of Demetris Zambas in a personal capacity and does not represent those of Pfizer.

Novo Nordisk’s Vice President for Clinical Data Operations and Insights Ibrahim Kamstrup-Akkaoui joins Richard this week for episode 4 of Season 3. As Ibrahim explains, the pace of innovation in clinical development is accelerating, sometimes generating billions of relevant data points for study teams to manage.

AI is already adding value and can help organizations sustainably manage this growth. They discuss how to start small and think big with AI and concrete examples of where it is delivering for Novo Nordisk, such as generating meaningful test data and study builds.

This discussion reflects the views and opinions of Ibrahim Kamstrup-Akkaoui in a personal capacity and does not represent those of Novo Nordisk.

Richard Young passes the torch to Manny Vazquez, our new podcast host, and shares his reflections before turning off his mic for the final time. Later, Manny is joined by renowned industry thinker and site leader Brad Hightower, owner of clinical research center Hightower Clinical in Oklahoma.

They discuss whether the growing tech burden is the price of progress for sites, plus tips on how sponsors can make sites’ lives easier. Brad also explains a few implications of the recent FDA draft guidance on DCTs and the upcoming site conference he helped to set up, ‘Save Our Sites’.

Manny Vazquez (our new host) interviews Trishna Bharadia, a patient engagement consultant and advocate. Since receiving a life-changing diagnosis 15 years ago, Trishna has made it her mission to strive for patient-centered healthcare.

This goal has recently taken on new urgency: the FDA and EMA are pushing sponsors for evidence that patient preferences are being accounted for in clinical research. Using real-life examples, Trishna and Manny discuss the benefits to sponsors of involving patients early in trial design and educating them on study findings.

As Trishna explains, patients will think of things sponsors won’t from living every day with their conditions.