Baxter Healthcare and Veeva MedTech

This video provides an in-depth testimonial from Baxter Healthcare regarding their strategic decision to implement the Veeva MedTech platform, specifically focusing on the Regulatory Information Management (RIM) Vault and its integration with PromoMats. The speaker, Larry Litle, details Baxter’s journey toward selecting a unified, cloud-based system to centralize their regulatory content and data, aiming for enhanced operational efficiency and streamlined global expansion. The process began with an extensive vendor evaluation, starting with approximately ten potential partners, which was eventually whittled down to three finalists before selecting Veeva due to the strength of its platform, technological capabilities, and commitment to customer needs through periodic updates and adaptive development.

A core driver for this significant capital expense—the adoption of a new RIM system—was the need to consolidate disparate regulatory information. Baxter sought to bring every country's marketing authorization and registration data into a single, accessible system. This centralization provides immediate, global access to critical information for colleagues worldwide, supporting the company's geographic expansion goals. The cloud-based nature of the platform was highlighted as a major benefit, ensuring accessibility regardless of location. Furthermore, the ability to create regulatory dossiers once and utilize them across multiple countries was identified as a key efficiency gain, allowing Baxter to manage global submissions more effectively and efficiently than their previous setup.

The implementation strategy emphasized the interconnectedness of the Veeva ecosystem. At the same time as rolling out the RIM Vault, Baxter was also deploying PromoMats, Veeva’s solution for promotional materials and content management. This simultaneous rollout was strategic, recognizing the inherent opportunities to build crucial connections between the commercial content managed in PromoMats and the regulatory data housed in the RIM Vault. This integration is vital for ensuring that promotional materials remain compliant with the latest regulatory approvals and marketing authorizations, bridging the gap between commercial operations and regulatory adherence.

Ultimately, the video underscores the transformational impact of a unified, cloud-based RIM system on a large, multinational life sciences organization. By moving away from fragmented systems, Baxter can leverage the Veeva platform to maximize data integrity, accelerate time-to-market in new geographies, and ensure that regulatory compliance is built into the content lifecycle from creation through submission and promotion. The focus remains on leveraging technology to achieve operational excellence in a highly regulated environment.

Key Takeaways: • Strategic Vendor Selection Process: Baxter undertook a rigorous evaluation process, initially reviewing around ten potential vendors before narrowing the field to three. The final decision hinged on technology capabilities, platform fit with the company vision, and the vendor's responsiveness to customer needs and commitment to platform evolution through periodic updates. • Justification for Capital Expense: The move to a comprehensive Regulatory Information Management (RIM) system was justified as a necessary capital expense driven by the need for efficiency and centralization, moving away from fragmented, inefficient legacy systems. • Single Source of Truth for Regulatory Data: The primary benefit of the RIM system is establishing a single source of truth for all global regulatory data, including every country's marketing authorization and registration information, making it instantly available to global teams. • Cloud-Based Global Accessibility: Utilizing a cloud-based platform ensures that colleagues around the world can access critical regulatory information anytime and anywhere, which is fundamental for supporting rapid geographic expansion and decentralized operations. • Efficiency in Global Dossier Management: The RIM system enables significant operational efficiency by allowing the creation of a regulatory dossier once and facilitating its use across many countries, streamlining the process of gaining and maintaining global marketing authorizations. • Integration of Regulatory and Commercial Content: Baxter strategically rolled out Veeva PromoMats concurrently with the RIM Vault to build necessary connections between promotional content management and regulatory data. This integration is crucial for maintaining compliance throughout the commercial content lifecycle. • Veeva Ecosystem Value: The decision highlights the value of the interconnected Veeva Vault ecosystem (e.g., RIM Vault and PromoMats), which allows for seamless data flow and process integration between regulatory affairs and commercial operations. • Focus on Platform Adaptability: A key factor in selecting Veeva was the vendor's "thirst" to understand customer needs and its willingness to adapt and make changes, ensuring the platform evolves to meet the complex and changing demands of the life sciences industry.

Tools/Resources Mentioned:

• Veeva MedTech
• Veeva RIM Vault (Regulatory Information Management)
• Veeva PromoMats (Promotional Materials Management)

Key Concepts:

• Regulatory Information Management (RIM): A critical system for life sciences companies used to manage, track, and submit regulatory information, marketing authorizations, and product registrations globally, ensuring compliance with health authority requirements.
• Marketing Authorization Registration: The process by which a regulatory body (like the FDA or EMA) approves a pharmaceutical product or medical device for marketing and sale within a specific jurisdiction.
• Dossier: A comprehensive collection of documents and data submitted to regulatory authorities to support an application for marketing authorization. The ability to "write a dossier once and use it in many countries" refers to leveraging common technical documents (CTD) structures for global submissions.