Advertise on podcast: Unblinded: A Clinical Trial Podcast

In this episode, host Manny Vazquez is joined by Noeleen Turner, head of clinical data management at UCB, and Anna Hayes, senior director of clinical data management at Veramed.   Using their breadth of experience and passion for a people-focused approach to clinical trial advancement, together they dive into hot topics like risk-based data management, the intricacies of change management in clinical data, and the growing importance of endpoint-driven design.

In this episode, we pull back the curtain on the monumental effort required to reshape global clinical trial standards. Manny and guests Lisbeth Bregnhoj and Cheryl Grandinetti explore why ICH E6(R3) is the catalyst the industry has been waiting for. From the intense complexity of dialing in language across regional borders to the latest push for a truly risk-based approach to clinical trials, the discussion highlights: A shift in strategy: Why the industry is finally moving away from "one-size-fits-all" in favor of flexibility and high-level data governance Defining quality: Breaking down what Critical-to-Quality (CtQ) factors actually look like in practice and how to align that understanding between sponsors, service providers, and investigators The future of inspections: It’s not just a change for sponsors – regulators are also facing a major shift in how they harmonize inspection techniques in a risk-based world

Brian Johnson, former head of R&D technology at Takeda, now consultant, shares his unique perspective on a topic that’s top-of-mind for many: how do you introduce new technologies and processes without alienating the people who need them most?   He and Manny also tackle the critical issue of health equity, examining how technology can help diversify clinical trials and, in turn, create a more equitable future for all. Join us as we explore the business case for change and the crucial steps needed to unstick the industry from its current trajectory.

Manny is joined by co-host Denali Rose and MSKCC’s Joe Lengfellner, to discuss the shifting focus from a one-size-fits-all approach to redefine site centricity. They talk about how the role of a clinical trial coordinator is changing, the challenges of managing data and protocol amendments across different systems, and the promise of technologies like EHR-to-EDC to streamline workflows. They debate the potential of LLMs to revolutionize patient recruitment and widen access to clinical trials, addressing the critical issue of reaching more diverse patient populations.

Join host Manny Vazquez as he sits down with Joyce Moore, leading voice in patient recruitment with over 25 years of experience in the industry, most recently at Allucent. In a field often focused on the logistics of data collection and study processes, Joyce offers a crucial perspective: seeing patients not as subjects, but as collaborators. She and Manny discuss the delicate balance of collecting essential data for clinical endpoints without overwhelming patients. Joyce also highlights the critical role of technology in enhancing the patient experience and the importance of keeping participants informed about their progress and the purpose behind the data being collected. Recorded at R&D and Quality Summit 2025 in Madrid.

Are we any closer to working out the human-machine relationship needed to embed AI in clinical development? To discuss this and all things automation, Veeva’s Chief Technology Officer Drew Garty joins host Manny Vazquez as he kicks off the new season with two innovators in the industry: Doug Bain, founder and consulting partner at Clinflo, and Robert Bergann, clinical digital innovation leader at Bayer. Recorded at R&D and Quality Summit 2025 in Madrid.

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.

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’.

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.

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.

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.

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

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 [email protected] 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)