The Human Cost of Fragmented Technology: A Conversation with Veeva’s Bree Burks

This video provides an in-depth exploration of the "human cost" of fragmented technology within clinical research sites, featuring a conversation with Bree Burks, VP of Strategy at Veeva. The discussion, recorded at the Veeva R&D and Quality Summit, highlights how the proliferation of disconnected systems in clinical trials leads to significant inefficiencies, burnout among highly motivated staff, and ultimately hinders patient care. Burks, drawing on her background as a nurse and study coordinator, emphasizes that while technology is intended to streamline processes, its current fragmented state often exacerbates chaos, forcing site staff to manually re-enter data across multiple platforms and perform redundant tasks.

The conversation delves into the reasons behind this persistent fragmentation, noting that sponsors and Contract Research Organizations (CROs) often adopt a "feature-function" approach, selecting different "best-of-breed" applications for individual studies without considering enterprise-level consistency. This leads to sites juggling upwards of six to ten systems per trial, on top of their own complex internal systems (some academic medical centers managing up to 26 internal systems). Burks argues that it's unrealistic to expect sites, which are focused on patient care rather than being technology businesses, to manage the complex integrations and frequent system changes. This mindset, where sponsors assume sites will simply adapt to new systems, overlooks the critical need for a holistic, platform-based approach that prioritizes the site experience and data standards.

A core theme is the tension between standardization and site autonomy. While sites often pride themselves on unique local practices, Burks asserts that "uncontrolled variation is the enemy of quality." She shares Veeva's experience in evangelizing standardization for regulatory documentation, initially met with resistance but eventually leading to significant innovation and efficiency gains for sites. This standardization has not only decreased monitoring burden and streamlined FDA inspections but also enabled the application of advanced technologies like AI bots for automated document classification. The video concludes by introducing Veeva's "three C's" framework—Consistency, Connectedness, and Comprehensiveness—and proposing a crucial fourth C: Community, fostering collaborative environments where sites and sponsors can drive meaningful progress together.

Key Takeaways:

• High Human Cost of Fragmentation: The primary consequence of fragmented technology in clinical trials is the burnout of dedicated research site staff, including nurses, physicians, and study coordinators. These professionals, passionate about patient care and bringing new medicines to life, are demoralized by repetitive manual data entry and working across disconnected systems.
• Unrealistic Burden on Sites: Clinical research sites are not technology companies; their core focus is patient care. Expecting them to manage complex integrations, adapt to numerous new systems per trial, and keep up with version changes for technologies that may be short-lived is unsustainable and detracts from their primary mission.
• Prevalence of Disconnected Systems: A significant majority (70%) of research sites are currently managing more than six different technology systems per clinical trial, in addition to their own substantial internal IT infrastructure (e.g., 26 internal systems at a large academic medical center).
• Sponsor-Driven Fragmentation: The root cause of much of this fragmentation lies in sponsors' historical approach of selecting "best for feature/function" applications for individual study teams, rather than adopting an enterprise-level strategy with consistent technology partners. This leads to constant switching of randomization technologies, patient questionnaires, and EDC systems.
• Need for a Platform Approach: To alleviate the burden on sites and drive efficiency, sponsors and CROs must shift to a platform-centric mindset. This involves partnering with technology companies that can offer a comprehensive suite of applications, providing consistency across trials and the entire organization.
• Technology Infuses Process: Modern technology implementations are not just tools; they mandate specific processes for sites. When sponsors layer numerous disparate systems onto sites, they inadvertently impose uncontrolled processes that sites often have no control over, leading to inefficiency and frustration.
• Standardization Drives Innovation: While sites may value autonomy, standardization is crucial for quality and innovation. Embracing consistent ways of working, particularly in areas like regulatory documentation, can lead to significant efficiencies, reduced monitoring burden, and enable advanced technologies like AI for automation.
• AI Enabled by Standardization: The adoption of standardized processes and data structures, such as consistent regulatory document management, creates the foundation for AI solutions. For example, AI bots can then effectively scrape and automatically classify documents, a capability that is impossible with uncontrolled variation.
• The Power of a Marketplace Model: The video uses the analogy of Zillow to illustrate the power of a platform that brings multiple stakeholders (buyers, sellers, realtors, data assets) together. A similar holistic platform approach is needed in clinical trials to connect sponsors, CROs, sites, and patients, facilitating better communication and data exchange.
• Veeva's 3 C's Framework: Bree Burks evangelizes a framework for improving the site experience centered on Consistency, Connectedness, and Comprehensiveness in technology solutions.
• The Fourth C: Community: Beyond technology, fostering a "Community" where sites and sponsors can engage in meaningful conversations with accountability is essential to address long-standing issues and drive collective progress in clinical research.
• Pushing for Regulatory Compliance: Sites must be empowered to adhere to federal regulations and their own SOPs, even if it means pushing back against outdated practices (e.g., a CRA requesting printed documents when electronic systems are compliant). Innovation sometimes requires standing firm on modern, compliant processes.

Tools/Resources Mentioned:

• Veeva Vault: Mentioned as a platform used by sites for managing regulatory documentation, demonstrating how standardization can lead to innovation and efficiency.
• Zillow: Used as an analogy for a powerful platform that brings multiple stakeholders and data assets together in a marketplace.
• iPhone: Used as an analogy for how simplicity and ease of use, often born from standardization, can drive innovation and widespread adoption.

Key Concepts:

• Fragmented Technology: The state where multiple, disconnected software systems are used for a single purpose or across an organization, leading to inefficiencies, manual data re-entry, and lack of a unified view.
• Human Cost of Fragmentation: The negative impact on individuals, such as burnout, reduced morale, and decreased job satisfaction, resulting from inefficient and frustrating technological environments.
• Feature-Function Focus: A strategy where technology selections are made based on the specific capabilities of an application for a particular task or study, often without considering broader integration or enterprise-level consistency.
• Platform Approach: A strategy that involves adopting a comprehensive, integrated suite of technologies from a single vendor or a tightly integrated ecosystem, aiming for consistency, connectedness, and comprehensiveness across an organization's operations.
• Data Standards: Agreed-upon rules and formats for data collection, storage, and exchange, which are crucial for effective integration and automation.
• Uncontrolled Variation: The lack of standardized processes or practices, leading to inconsistencies that hinder quality, efficiency, and the ability to leverage advanced technologies.

Examples/Case Studies:

• Academic Medical Center System Overload: An example of a large academic medical center struggling to integrate 26 internal systems, highlighting the immense challenge when sponsor systems are added on top.
• Veeva Vault for Regulatory Documentation: A real-world example of how Veeva initially faced resistance from sites regarding standardizing regulatory document management but ultimately demonstrated how standardization led to innovation, reduced monitoring burden, and enabled AI capabilities.
• CRA Requesting Printed Documents: A personal anecdote from the interviewer about a CRA requesting printed e-reg binder documents, illustrating the need for sites to uphold modern, compliant electronic processes against outdated practices.