Meet with Veeva!

This video provides an in-depth exploration of Veeva Systems' vision for transforming clinical trials through digital innovation, focusing on speed, efficiency, and compliance. Bree Burks, a representative from Veeva, outlines the company's commitment to creating an end-to-end operating system for new product development in human health. The presentation, delivered to "Black Women In Clinical Research," details how Veeva is bridging content gaps and fostering global harmonization while supporting local autonomy in clinical research. Burks emphasizes Veeva's transition to a Public Benefit Corporation, signaling a long-term commitment beyond just profits, focusing on societal benefit, employees, customers, and human health.

The core of Veeva's strategy revolves around "digital trials," which go beyond mere decentralization to encompass paperless, electronic, and truly synchronized processes. This approach aims to reduce trial costs and timelines by 25% by 2025, addressing the industry's current challenges of disconnected technologies, manual administrative tasks, and site burnout. Veeva's unified Vault platform serves as the foundation, integrating data, documents, and workflows across various applications, including quality, regulatory, clinical operations, safety, and commercial cloud. A significant portion of the discussion is dedicated to patient-centricity, exemplified by the MyVeeva for Patients application, which aims to provide a seamless, single-login experience for participants, contrasting with the current fragmented app landscape.

A key differentiator highlighted is Veeva's "Site Connect" initiative, designed to automate the exchange of documents and information between sponsor/CRO systems (like Veeva TMF) and site systems (Veeva SiteVault). This direct, middleware-free connection addresses the massive administrative burden of document exchange, particularly for the 60% of TMF documents originating from sites. The e-consent process is presented as a concrete example of digital transformation, where consent templates are electronically sent, reviewed, approved by IRBs within the system, and then securely delivered to patients via MyVeeva, with automatic filing and version control. Furthermore, Veeva SiteVault is offered free to sites, providing a structured investigator site file and robust remote monitoring capabilities, allowing CRAs to access certified copies of source documents and engage in real-time document review and communication within the platform.

Key Takeaways:

• Veeva's Public Benefit Corporation Status: Veeva transitioned to a Public Benefit Corporation in 2023, legally committing to a vision beyond profits, focusing on society, employees, customers, and human health, signaling a long-term dedication to industry transformation.
• End-to-End Operating System Vision: Veeva aims to provide a comprehensive operating system for the entire R&D process, from clinical operations to commercialization, connecting all stakeholders and applications to bring new products to market efficiently.
• Digital Trials vs. Decentralized Trials: Veeva's "digital trials" vision emphasizes paperless, electronic, and synchronized processes across all trial types, not just decentralized ones, with a goal of reducing trial costs and timelines by 25% by 2025.
• Patient-Centric Technology (MyVeeva for Patients): MyVeeva for Patients is an application designed for patients to provide a single, seamless, and synchronized experience for all trial-related interactions, contrasting with the current disconnected app landscape for participants.
• Transformative E-Consent Process: Veeva's e-consent system enables electronic template exchange between sponsors/CROs and sites, in-system IRB approval, and direct, secure delivery to patients via MyVeeva, ensuring version control, automatic filing, and the ability to embed rich media and capture structured data.
• Site Connect for Automated Document Exchange: Site Connect facilitates automated, direct document exchange between Veeva TMF (used by 60% of industry-sponsored studies) and Veeva SiteVault, eliminating manual email attachments and reconciliation for regulatory and source documents.
• Benefits of Connected Studies: This connectivity reduces manual administrative burden, improves compliance by ensuring correct document versions are used and filed, enhances sponsor-site relationships, and provides cross-coverage for site staff.
• Veeva Vault's Unified Architecture: All Veeva applications are built on a unified Vault platform, integrating data, documents, and workflows, ensuring seamless information exchange and improved functionality as more applications are adopted.
• Free SiteVault for Sites: Veeva SiteVault is provided free of charge to sites, offering a comprehensive electronic investigator site file (eISF), e-consent, patient status tracking, and digital delegation logs, with documents hosted for 25 years.
• Enhanced Remote Monitoring Capabilities: SiteVault supports advanced remote monitoring by allowing CRAs to access certified copies of site source documents, annotate, stage reviews, and track monitoring activities within the same Vault environment.
• Challenges in Digital Adoption: A significant hurdle remains the transition of paper documents into electronic systems, although Veeva is developing tools like the TMF bot (using AI for auto-classification) and streamlined upload processes to ease this burden.
• Industry Mindset Shift: The speaker advocates for the industry to value "connection over customization" to achieve true optimization and standardization, as excessive customization can hinder seamless integration and automation.
• Future Developments: Veeva is continuously building, with plans to expand MyVeeva for Patients beyond e-consent to include all patient-related documents and communications, and to integrate granular patient visit data from SiteVault with payment systems.
• Career Opportunities at Veeva: Veeva actively recruits individuals with clinical operations experience, particularly those interested in consulting roles for technology implementation, with a strong commitment to diversity and inclusion.

Tools/Resources Mentioned:

• Veeva Vault: The foundational platform for all Veeva applications.
• Veeva SiteVault: A free eISF and site operations system for clinical research sites.
• MyVeeva for Patients: A patient-facing application for engaging with clinical trials.
• Veeva TMF (Trial Master File): A flagship product for managing sponsor/CRO trial documents.
• Veeva CDMS (Clinical Data Management System): An EDC-plus system for modern data management, including IRT/IWR capabilities.
• Veeva CTMS (Clinical Trial Management System): For managing clinical trial milestones and operations.
• Veeva Study Startup: An application for tracking and managing study startup processes.
• Veeva Payments: A system for managing site payments, linked to CTMS.
• Site Connect: A feature enabling automated document exchange between Veeva TMF and SiteVault.
• TMF Bot: An AI-powered tool for scraping and auto-classifying documents in the TMF.
• clinicaltrials.viva: An upcoming application described as a "LinkedIn for clinical trials."

Key Concepts:

• Digital Trials: A comprehensive approach to clinical trials that are paperless, electronic, and synchronized, aiming for process transformation rather than just decentralization.
• Patient-Centricity: Designing clinical trial processes and technologies with the patient experience at the forefront, ensuring ease of participation and engagement.
• Connected Studies: The concept of seamlessly linking sponsor/CRO systems with site systems to automate document and information exchange, reducing manual effort and improving data flow.
• Unified Vault Platform: Veeva's proprietary architecture where all applications are built on a single, integrated platform, allowing for shared data, documents, and workflows.
• Public Benefit Corporation (PBC): A legal structure for a for-profit corporation that is committed to operating in a way that benefits society, employees, customers, and shareholders.
• E-consent: The electronic process of obtaining informed consent from trial participants, often incorporating interactive elements and digital signatures.
• Remote Monitoring: The practice of monitoring clinical trial data and documents remotely, often leveraging electronic systems to access site files and conduct source data verification (SDV).
• Source Data Verification (SDV): The process of ensuring that data recorded in the case report forms (CRFs) matches the original source documents at the clinical site.

Examples/Case Studies:

• Pfizer Vaccine Study: Mentioned as an example of patients experiencing a fragmented and disconnected technology experience with multiple apps for a single trial.
• Bayer: Identified as the first early adopter of Veeva's Site Connect technology for automated document exchange.
• IRB Approvals: Veeva worked closely with major IRBs like WCG and Advarra, as well as academic medical centers such as Hopkins, Vanderbilt, and Penn, to get their e-consent technology approved and gather feedback.