Welcome to the Veeva R&D Quality Summit, where we explore the latest innovations in clinical trials. Today, Richard Young, VP of Clinical Data Strategy at Veeva Systems, shares his insights on connected clinical trial applications, AI, automation, and site collaboration.
Moe Alsumidaie: How is the theme of connected applications highlighted at the summit?
Richard Young: The word “connected” is key here. We have 3,000 people at the summit to connect. For me, connecting users through data is vital. It’s about every contributor and consumer of data in the process, focusing on patients and sites to ensure trials make sense. Ultimately, it’s about ensuring the data is robust and stands up to scrutiny, ensuring it is fit for purpose. This means focusing on patients and sites to ensure trials make sense and that the data stands up to scrutiny. For example, think of a Rubik’s cube. Solving problems in data management is like solving a Rubik’s cube; you can only see three sides at a time, representing different participants like sites, patients, and data managers. Every move impacts others, and sometimes, you must sacrifice progress on one side to advance on another. This analogy underscores the importance of a connected journey where everyone collaborates rather than working in silos.
Moe Alsumidaie: What developments around smart automation are you excited about?
Richard Young: The AI hype has peaked, and there’s a risk of disappointment. Last year, we decided not to invest heavily in AI immediately, but to enable AI and automation by focusing on data infrastructure. Automation is critical, and we’re seeing significant improvements in data management without AI, just through clever automation. This has led to double-digit percentage reductions in time, effort, and cost. For example, some customers have reported being 20% to 40% faster in data cleaning and management processes through automation. In some cases, protocol amendments have been 90% faster. These improvements are achieved without AI by connecting users, optimizing processes, and generating high-quality results. This shows that automation can deliver substantial value and efficiency gains.
Moe Alsumidaie: Can innovation be pushed too fast in clinical trials?
Richard Young: I don’t think you can push it too fast. However, we are a conservative industry for good reasons. It’s about appropriate risk and innovation. Pragmatic and flexible approaches are essential and align with FDA’s initiatives. Successful innovation should be easily adoptable and demonstrate quick returns. We use the term “pragmatic” to emphasize that innovation should return value and be easily adoptable. For instance, holding on to past methods can inhibit future progress, much like holding on to two solved sides of a Rubik’s cube prevents solving the rest. Innovation requires letting go of old practices to achieve better outcomes.
Moe Alsumidaie: What new insights or innovations at the summit can enhance site collaboration?
Richard Young: We have 60 clinical research sites here, which is a new territory in bringing the industry together. Listening to sites is crucial. We need to understand their needs and challenges. Giving sites a platform to voice their opinions can dispel previous assumptions and improve collaboration, significantly reducing startup times and making the process more efficient. Sites control many aspects of the trial process. By listening to sites, we can bring trials to patients, reducing travel and making participation easier. This changes the dynamics and allows for more efficient and practical research. For instance, reducing startup times from months to days can significantly accelerate the trial process. By understanding their needs, we can make trials more accessible and efficient, benefiting patients and speeding up the development of new therapies.
Moe Alsumidaie: Is there anything else that excites you about this conference?
Richard Young: As a data manager, I’m excited about the clinical data coming out party. We’re moving beyond individual tools to a truly connected journey. This transformation allows for better primary, secondary, and tertiary uses of data. We’re not finished, but we have a blueprint for transforming the industry and enabling our partners to complete other journeys. Historically, we’ve focused on individual applications like EDC. Now, we’re looking at a connected end-to-end process that can retool the industry. This approach improves the first use of data and enables secondary and tertiary uses, providing more value and insights. It’s about building tools our partners and customers can use to drive innovation and efficiency.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
