Henry Levy invites you to R&D Summit

This video serves as an invitation from Henry Levy, General Manager for Veeva Vault CTMS (Clinical Trial Management System), to the Veeva R&D Summit in Philadelphia. The primary context of the invitation is to highlight the significant progress and maturation of Veeva’s solutions in the clinical operations space, particularly focusing on their Electronic Data Capture (EDC) offering and the broader goal of revolutionizing clinical data management. Levy uses his personal experience—joining Veeva three years prior and participating in a demo of a "very, very early EDC solution"—to frame the rapid evolution of the technology.

The core message emphasizes the transition from nascent technology to an established, market-tested platform. Levy provides specific, albeit brief, metrics demonstrating this growth: in the three years since the initial demo, Veeva’s EDC solution has been utilized to run almost 40 clinical studies, with nearly 10 studies having reached the lock stage. This rapid adoption and successful completion of trials underscore Veeva’s commitment to disrupting traditional clinical data management systems. The progression of ideas moves from a historical anecdote to current success metrics, culminating in a call to action for industry leaders to attend the summit to share in this journey and contribute feedback.

The speaker’s perspective is one of excitement and partnership, positioning the R&D Summit not just as a showcase for innovative technology, but as a collaborative forum. The explicit request for attendees to "help us" and "tell us how we can continue to improve the data management space" highlights Veeva’s reliance on customer feedback to refine its regulated enterprise software. This approach suggests a continuous development cycle driven by the practical needs of pharmaceutical, biotech, and medical device companies, aiming to fully capitalize on the benefits of modern technology within the highly regulated clinical trial environment. The overall theme is the successful integration of technology into R&D processes to enhance efficiency and compliance in clinical data management.

Key Takeaways: • Rapid Maturation of Veeva Clinical Solutions: The video confirms the accelerated growth and market acceptance of Veeva’s R&D suite, moving from an early-stage EDC demo to a solution running approximately 40 clinical studies and locking 10 within a three-year span. This validates Veeva’s aggressive push into the clinical operations technology market. • Focus on Clinical Data Management Revolution: The central strategic goal articulated is the revolutionization of clinical data management, indicating that Veeva is actively challenging traditional, often fragmented, systems with integrated, cloud-based solutions like Vault CTMS and EDC. This represents a significant shift in industry standard operating procedures. • Importance of Integrated CTMS and EDC: The speaker, as the General Manager for Vault CTMS, links the success of the EDC solution directly to the broader Vault platform, emphasizing the value of having core clinical trial management and data capture functions unified within a single ecosystem. This integration streamlines workflows and improves data integrity. • Customer-Centric Development Model: Veeva explicitly invites industry leaders to the R&D Summit to provide feedback, underscoring a commitment to a customer-driven development cycle. For consulting firms, this signals that successful Veeva implementations must incorporate client-specific operational needs and feedback loops. • Proof Points for Adoption: The metrics provided (40 studies run, 10 studies locked) serve as crucial proof points for potential clients and partners, demonstrating the reliability and regulatory compliance of the system for managing end-to-end clinical trials, including the critical study lock milestone. • Strategic Opportunity in R&D Operations: The focus on the R&D Summit confirms that Veeva is heavily investing in the clinical, regulatory, and quality sectors, moving beyond its traditional strength in commercial CRM. This expands the scope of required expertise for consultants specializing in Veeva systems. • Technology Capitalization in Regulated Space: The speaker stresses the need to "capitalize on the benefits of technology in this important space," which directly aligns with IntuitionLabs’ mission to deploy AI and custom software to optimize regulated processes like clinical data handling and compliance tracking. • Target Audience Alignment: The R&D Summit targets leaders in clinical, regulatory, quality, and IT—the precise departments within pharmaceutical and biotech companies that IntuitionLabs serves, confirming the relevance of these topics to the company’s sales and service strategy.

Tools/Resources Mentioned:

• Veeva Vault CTMS (Clinical Trial Management System): A core product within the Veeva R&D suite designed to manage the lifecycle of a clinical trial.
• Veeva EDC (Electronic Data Capture): The specific solution mentioned for capturing and managing clinical trial data electronically.
• Veeva R&D Summit: The annual industry event serving as a platform for sharing best practices and technology updates in clinical, regulatory, and quality operations.

Key Concepts:

• Clinical Data Management (CDM): The process of collecting, cleaning, and managing data from clinical trials in compliance with regulatory standards (e.g., GxP, 21 CFR Part 11). The video positions Veeva’s solutions as revolutionary tools for modernizing CDM.
• Study Lock: A critical milestone in a clinical trial where the database is finalized and "locked," meaning no further changes can be made to the data before analysis and submission to regulatory bodies. Achieving 10 study locks demonstrates the system's maturity and regulatory readiness.