Season 1 Episode 2: Three Pillars of PV Transformation: Technology, Process, and People

This video provides an in-depth exploration of Pharmacovigilance (PV) transformation, focusing on the three critical pillars: Technology, Process, and People. Hosted by Veeva Systems, the discussion features consultants from Eliquent Life Sciences (formerly Truliant Consulting), who offer historical context on how PV operations have evolved—from the days of typewriters and disparate, homegrown systems to the current complex global landscape. The speakers highlight that early PV environments were characterized by low-tech operations and localized processes, which have since been complicated by globalization, increasing regulatory demands, and the proliferation of point solutions.

A major theme explored is the downstream business challenge resulting from this historical evolution. Companies now struggle with managing global environments across time zones and cultural barriers, exacerbated by localized regulations (e.g., stricter rules emerging in China and Korea) that often lead to segregated systems and processes (e.g., Japan operating completely detached from global PV). This fragmentation results in a high cost of maintaining and upgrading numerous disparate systems that were never built to communicate, leading to unmanageable complexity and unsustainable operations. PV leaders are now actively seeking platform approaches that enable end-to-end harmonization and standardization across the globe, aiming for maximum operational efficiency and simplification.

The consultants emphasize that technology alone cannot drive transformation; the pillars of Process and People are equally vital. They advocate for a top-down approach to process harmonization, starting with stakeholder identification and management. A key methodology employed is the "Five Whys" technique to deeply understand current processes, uncover workarounds, and identify the true underlying reasons for existing inefficiencies. Regarding the 'People' pillar, the discussion stresses the necessity of early and continuous change management, recognizing that large-scale projects often face resistance, especially concerning the adoption of AI. The speakers counter the fear of job displacement by reframing AI's role as an enabler to cope with increasing data volumes (e.g., from wearables) and decreasing budgets, allowing PV professionals to focus on higher-value tasks like signal detection and patient safety.

Furthermore, the video addresses the critical role of external stakeholders, including other internal departments (Clinical, Quality, Medical Information) and Contract Research Organizations (CROs). Achieving cross-functional connectivity requires standardizing data quality upfront, often necessitating large data cleaning projects to ensure consistent terminology and language across functions before system migration. CROs are identified as crucial partners who possess deep knowledge of the sponsor's data and current operational pain points, making their early involvement in design workshops and data migration planning essential for project success. The consultants conclude by sharing lessons learned, advising against attempting to change all systems and processes simultaneously due to decision fatigue, and predicting that future PV innovation will involve AI automating routine tasks like updating SOPs and training materials, necessitating a shift in the required skill sets of PV professionals.

Key Takeaways: • Prioritize Platform over Point Solutions: Historically, new regulations led to the adoption of bolt-on point solutions, creating unmanageable complexity; PV leaders must now shift toward comprehensive platform approaches to achieve end-to-end harmonization and reduce the high cost of system maintenance and upgrades. • Change Management Must Start Early: Change management is not merely training at the end of a project; it must begin at the outset with steady, skilled engagement to monitor organizational temperature, address open wounds from past failed implementations, and ensure sustained adoption post-go-live. • The "Five Whys" for Process Design: To design an effective future state, consultants use the "Five Whys" technique to peel back layers of existing processes, uncover workarounds, and understand the true reasons behind current operational inefficiencies. • Establish Guiding Principles for Consensus: Before designing detailed future state processes, project teams must agree on a common set of guiding principles to ensure all stakeholders (including representatives from Quality and Clinical) are working toward the same goal, accelerating decision-making and consensus. • Address AI Anxiety Proactively: When introducing AI, project objectives must be clearly communicated to alleviate fears of job displacement; AI should be framed as a tool to handle increasing data volumes and budget constraints, enabling staff to focus on critical patient safety activities. • Data Standardization is Foundational: Connecting different functional domains (PV, Quality, Clinical) is technically easy, but functionally difficult without standardized data. Significant time must be budgeted for cleaning "dirty data" and aligning on common language and terminology across departments to ensure effective signal detection and system interoperability. • Involve CROs Early and Deeply: CROs often know the sponsor's data and operational pain points better than the sponsor's oversight team; they must be included in design, process, and data migration workshops as crucial stakeholders, even if their long-term partnership status is uncertain. • Avoid Decision Fatigue via Phased Rollouts: Do not attempt to change every system, process, and country simultaneously. Transformation should be sequenced logically (e.g., safety database first, then intake automation, then translation tools) to prevent stakeholder burnout and decision fatigue. • Ensure Adequate Business-as-Usual Coverage: Sponsors must budget for robust external support or internal backfilling to ensure that business-as-usual operations and compliance activities (including unplanned inspections) can continue uninterrupted while internal resources are dedicated to the transformation project. • Visibility of Project Sponsors is Key: High-level sponsor visibility (e.g., having them open kickoff meetings) demonstrates the project's weight and importance, boosting morale, engagement, and the overall success trajectory. • Leverage Peer-to-Peer Learning: PV companies should connect with other organizations undertaking similar transformation journeys to share lessons learned, brainstorm solutions, and collaborate, recognizing that PV is a patient safety function, not a competitive sales area. • Future PV Skills Will Shift: The coming automation of tasks like updating SOPs, training materials, and user manuals using AI engines will necessitate a change in the required skill profile of PV professionals, demanding new competencies to manage and validate these automated outputs.

Tools/Resources Mentioned:

• Veeva Systems Inc: Host of the podcast, focusing on platform solutions for the life sciences industry (specifically PV/Safety).
• Eliquent Life Sciences (formerly Truliant Consulting): Consulting firm specializing in safety, quality, and regulatory transformation projects.

Key Concepts:

• Pharmacovigilance (PV) Transformation: Large-scale projects focused on modernizing the systems, processes, and organizational structure used to monitor the safety of medicines.
• Five Whys: A root cause analysis technique where the question "Why?" is asked repeatedly (typically five times) to drill down to the underlying cause of a problem or inefficiency.
• Platform Approach: Moving away from multiple, disconnected point solutions toward an integrated, unified software environment (like those offered by Veeva) that supports end-to-end processes across different functions and geographies.
• Decision Fatigue: The psychological phenomenon where the quality of decisions deteriorates after an extended period of decision-making, a common pitfall in large, complex transformation projects.