Unblinded: A Clinical Trial Podcast

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.

In this insightful discussion, Doug Bain, founder of ClinFlow, Drew Garty, CTO at Veeva, and Robert Bergann, leader of clinical digital innovation at Bayer, delve into the transformative power of AI in clinical development. They share practical AI use cases like pattern detection and the innovation of automated study builds. The guests also discuss the importance of human oversight in AI outputs, effective governance for AI strategies, and the need for proactive detection methods. Their call to action emphasizes focusing AI on patient benefits and quality data.

Manny Vazquez chats with Trishna Bharadia, a passionate patient engagement consultant and advocate, dedicated to making healthcare more patient-centered since her own life-altering diagnosis 15 years ago. They delve into how involving patients early in clinical trial design can lead to breakthroughs in care. Trishna shares insights on overcoming challenges and emphasizes the necessity of diverse patient perspectives. The conversation envisions a healthier future by advocating for equity and removing barriers to access in the medical field.

Brad Hightower, owner of Hightower Clinical, dives into the challenges of balancing technology with clinical trial efficiency. He discusses whether the increasing tech burden is justified for progress and shares insights on how sponsors can ease site operations. The conversation highlights the implications of recent FDA guidance on decentralized trials and the importance of fostering communication between sites and sponsors. Brad also teases the upcoming ‘Save Our Sites’ conference aimed at revolutionizing site support.

Ibrahim Kamstrup-Akkaoui, Vice President for Clinical Data Operations at Novo Nordisk, shares insights from his journey in IT and clinical data management. He discusses the rapid growth of data in clinical trials and how AI can be harnessed to manage this effectively. Key topics include the transition from legacy systems to robust digital platforms, the importance of patient-centric design, and practical AI applications that enhance efficiency in trial setups. Ibrahim emphasizes starting small with innovative solutions while keeping a visionary outlook for scaling technologies.

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!