Season 2 Episode 6: Transforming Clinical Operations: What Comes Next?

This podcast episode, hosted by Veeva Systems, features an in-depth conversation with Emma Earl, Bayer’s Head of Clinical Trial Management Services and Solutions, focusing on the dramatic transformation of clinical operations over the last two decades and the challenges and opportunities that lie ahead. The discussion centers on the shift from legacy paper-based systems to modern digital platforms, emphasizing the critical balance between people, process, and technology required to deliver efficient and patient-centric clinical trials. Emma Earl, drawing on over 20 years of industry experience, provides a perspective rooted in operational history, having transitioned from a Clinical Research Associate (CRA) role into defining and implementing clinical trial technologies, including a significant focus on Veeva Vault clinical implementations.

A major theme explored is the industry's evolution from completely paper-based processes—including paper CRFs, manual data entry, and physical document handling—to the current digital landscape utilizing Electronic Data Capture (EDC) and modern Clinical Trial Management Systems (CTMS). This transition, while initially met with skepticism, has provided crucial visibility and transparency, enabling organizations like Bayer to look across studies, identify trends, and assess overall performance metrics. Earl highlights that the complexity of modern protocols, including those for advanced research like gene and cell therapies, necessitates flexible systems and processes that can accommodate "edge cases" without creating 25 different workflows, driving the need for a simplified, consolidated technology landscape.

The speakers dedicate significant time to the perennial challenge of balancing people, process, and technology. While technology enables efficiency and reduces errors, the human element remains paramount, especially since clinical research fundamentally occurs when people (site staff, patients) interact. Earl argues that technology should serve to enable people, making processes better and easier. She stresses that the ultimate goal is not just adding new functionality but fixing existing problems, exemplified by the energy derived from successful process simplification, such as reducing the number of system roles. Furthermore, the conversation addresses the evolving definition of "monitoring," which has broadened beyond the traditional CRA role to include collaborative data review between clinical operations and data management, necessitating clear role definitions to avoid inefficiency and duplication of work.

Detailed Key Takeaways

• Consolidating the System Landscape is a Key Priority: Bayer's current focus is streamlining its technology environment by minimizing the need for complex integrations and leveraging platform features (like Veeva Vault) where possible. The goal is to achieve a simpler, more efficient landscape, with the ultimate win being the ability to retire legacy systems (e.g., a final Legacy CTMS).
• Process Re-evaluation Must Accompany Technology Implementation: Implementation projects should be used as opportunities to critically revisit and question existing processes, rather than simply "lifting and shifting" old workflows onto new technology. This ensures that new systems are utilized to their full potential for optimization.
• Inefficiency is the Primary Target for Elimination: The greatest wish for transformation is the elimination of inefficiency—getting rid of unnecessary steps and processes that exist only because of historical incidents or inertia. Organizations must be willing to stop and rethink whether long-standing processes are still required.
• Scientific Complexity Drives Operational Challenges: The increasing complexity of clinical protocols, especially in advanced therapies, demands systems and processes that can accommodate numerous "edge cases" without sacrificing standardization or creating overly fragmented workflows.
• People are the Most Important Element in the Triad: While technology and process are critical, clinical trials cannot function without people. Technology's role is to enable staff to perform better, recognizing that success hinges on people's willingness and mindset to leverage new processes and systems.
• Site Centricity is a Catalyst for Overall Success: Solving the problem of making sites happy is identified as the single most impactful change an organization can make. Site satisfaction has a huge knock-on effect on patient experience and the sponsor's ability to run trials quickly.
• Avoid Disproportionate Prioritization of Users: The industry often vacillates between focusing heavily on sites or heavily on patients. True success requires a balancing act—solving the "Rubik's Cube" by addressing the needs of all six sides (all stakeholders) simultaneously.
• The Definition of Monitoring Has Evolved: The term "monitoring" is now much broader than traditional CRA site visits. Clarity is needed between clinical operations and data management regarding their respective roles in data review and oversight to ensure efficient collaboration and prevent duplication of effort.
• Early, Broad Exposure is Formative for Leaders: Starting in a small biotech or CRO, where individuals are exposed to a wide range of tasks (e.g., data management, monitoring, closeout visits), provides a critical foundation and broad experience that shapes future technology and process definition roles.
• Learning Comes from Problem Solving: As an industry lesson, it is crucial to remember that "you never learn anything from something that goes well." Troubleshooting and problem-solving exercises, often triggered by new scientific or operational scenarios, generate energy and lead to innovation.

Key Concepts

• Veeva Vault Clinical Implementations: The use of Veeva's suite of clinical applications (e.g., CTMS, eTMF) to manage and execute clinical trials, a core technology focus for Bayer's clinical operations team.
• Incompetence Intolerance: A personality trait described as a strength, where individuals are driven by a desire to fix inefficient or poorly designed processes, often leading them toward technology and process optimization roles.
• Site Centricity: The strategy of designing clinical trial processes and technology solutions with the needs and pain points of the investigative sites (hospitals, clinics) as a primary focus, recognizing their crucial role in patient interaction and data collection.
• Legacy CTMS: Older, often fragmented or non-integrated Clinical Trial Management Systems that modern organizations are actively trying to replace or consolidate into unified platforms.

Examples/Case Studies

• The Shift from Paper-Based Monitoring: The speaker recalls the early days of monitoring, involving paper CRFs, DCFs, green pens, Post-it notes, and physically bundling documents in cars—a stark contrast to current digital access via websites and EDC systems.
• EDC Adoption Skepticism: The initial rollout of laptops for Electronic Data Capture (EDC) was met with widespread industry skepticism that "this is never going to work," highlighting the initial resistance to digital transformation.
• Collaboration-Driven Process Change: Bayer recently had to re-evaluate how they number their studies due to a new collaboration, demonstrating how external factors force internal process adjustments and problem-solving exercises within the team.