GSK: Preparing Business for Study Start-up Change - Overview

This video provides an in-depth overview of GSK’s comprehensive "unified technology journey," specifically detailing their transformation efforts within Clinical Operations using the Veeva Clinical Vault program. The primary goal of this initiative was to consolidate disparate clinical operations and technology solutions under a single umbrella to maximize value, drive efficiency, and achieve industry-leading study start-up (SSU) timelines. GSK structured this major business change around three core pillars: People, Process, and Technology, emphasizing that success requires balancing all three, rather than favoring one over the others. The presentation highlights the critical need for this transformation, noting that GSK was previously trailing industry benchmarks in study start-up timelines due to siloed systems and reliance on manual processes, such as Excel trackers.

The transformation strategy focused heavily on improving the user experience for clinical operations staff. From a "People" perspective, the initiative aimed to build staff capabilities and ensure talented employees spent time on high-value activities instead of navigating non-integrated systems. This was supported by the introduction of a global study start-up team tasked with challenging conventional decisions, leveraging data, and enabling the necessary cultural shift toward metrics-driven performance. On the "Process" front, the Clinical Vault implementation served as a catalyst to standardize ways of working across different business units and study phases. By starting with a "blank sheet of paper," GSK aligned processes based on regulatory requirements rather than historic, siloed practices, simplifying workflows to work seamlessly with the new technology.

Technologically, the shift involved creating a unified clinical ecosystem with a single entry point for workflows, providing staff with a complete view of operations. This unified approach not only improved the user experience but also enabled integrated reporting, which was crucial for improving data quality and driving data-driven decisions—a key ambition for the organization. Specifically within Veeva SSU, the integration of systems and simplification of processes allowed GSK to achieve industry-leading timelines for some priority studies, significantly accelerating the journey from Final Protocol Approval (FPA) to First Subject First Visit (FSFV).

The presentation concludes by emphasizing the strategic necessity of a cross-Vault mindset, moving away from managing singular applications toward viewing the entire Veeva ecosystem as interconnected. Furthermore, the success of the transformation hinged on robust change management, requiring dedicated time and resources to address changes in systems, culture, and mindset. This involved engaging end-users early, identifying change champions, and building a system that inherently suits user needs to maximize adoption upon go-live.

Key Takeaways

• Balanced Transformation Framework: Major business change, such as optimizing study start-up, must be driven by a balanced focus on People, Process, and Technology; favoring one pillar over the others will undermine the effectiveness of the transformation.
• User Experience is Paramount: Improving the user experience for clinical operations staff is critical for efficiency gains. The goal is to ensure talented staff spend time on activities that truly matter, eliminating the need to revert to manual tools like Excel trackers due to poor system integration.
• Technology as a Catalyst for Process Change: The implementation of a unified technology platform (Veeva Clinical Vault) should be used as a catalyst to challenge and standardize historic ways of working, aligning processes across business units based on current regulatory requirements rather than past practices.
• Shift to Data-Driven Decision Making: The unified clinical ecosystem enables integrated reporting and improved data quality, which is essential for moving toward much more data-driven decisions in clinical operations and SSU.
• Organizational Enablement is Required: GSK introduced a global study start-up team to sit on central teams, helping to drive alignment, challenge decisions based on metrics, and enable the cultural shift required to move from "safe timelines" to ambitious, industry-leading performance goals.
• Focus on Regulatory Requirements: When simplifying processes, organizations should start with a blank sheet of paper and focus on what regulators actually require, rather than replicating complex, historic, and often siloed business unit-specific workflows.
• Cross-Vault Strategy is Essential: Organizations must adopt a cross-Vault mindset, understanding how decisions made in one application (e.g., SSU) impact and require buy-in from other applications within the larger Veeva ecosystem.
• Agile Decision-Making Structure: The transformation team needs to be structured to drive alignment while remaining lean and agile, enabling quick decisions regarding system configuration and business change enablement.
• Measure FPA to FSFV: A key metric for success in SSU is the speed of turnaround between Final Protocol Approval (FPA) and First Subject First Visit (FSFV); GSK is now seeing industry-leading timelines for priority studies through this combination of factors.
• Prioritize Change Management: Dedicating sufficient time and resources to change management is non-negotiable for success. This includes involving end-users and change champions from the start to build a system that meets their needs and increases adoption rates immediately upon go-live.

Tools/Resources Mentioned

• Veeva Clinical Vault
• Veeva SSU (Study Start-Up)

Key Concepts

• Unified Technology Journey: A strategic initiative to bring together multiple clinical operations and technology solutions under a single, integrated platform (like Clinical Vault) to maximize value and efficiency.
• Study Start-Up (SSU): The critical phase in clinical trials encompassing activities between final protocol approval and the first subject being enrolled (First Subject First Visit - FSFV).
• Cross-Vault Mindset: A strategic approach to managing the Veeva ecosystem where changes and decisions are considered across all integrated Vault applications, rather than treating each application in isolation.