Veeva: 제품 소개 영상1

The video introduces the Veeva Vault Clinical Suite, positioning it as the industry’s first and only unified solution designed to address the increasing complexity of managing global clinical trials. The presentation begins by outlining the core challenge faced by pharmaceutical and life sciences companies: the necessity of relying on disparate, multi-system environments. Historically, companies have used separate systems for creating study documents (like protocols), collecting site content (such as CVs and financial documents), tracking study milestones, and documenting compliance with local regulatory requirements. This fragmentation, compounded by constant changes and regional variations, results in information silos, requiring endless hours of manual effort—sifting through spreadsheets, emails, and various systems—to gain a complete view of even a single study, let alone an entire program.

The core innovation presented is the integration of CTMS (Clinical Trial Management System), eTMF (electronic Trial Master File), and Study Startup applications into a single process, system, and view. This unification is possible due to the Veeva Vault platform's unique technological capability to manage both structured data (like trial activities and milestones) and unstructured content (like regulatory documents and site files) simultaneously. By eliminating the traditional technology limitation where platforms could only handle one or the other, the Vault Clinical Suite establishes a unified system for all clinical operations information and documentation, thereby streamlining clinical processes and eliminating pervasive information silos.

This single-system approach transforms how sponsors, investigators, and Contract Research Organizations (CROs) collaborate. They now work within one system, ensuring a single source of truth for all trial content and data, which provides a complete, global view of study operations. The benefits highlighted include real-time visibility for investigators regarding study updates, the ability to enter trial information once and leverage it across multiple sites and countries, and automated assurance that all required content is collected and current. Ultimately, the system is designed to accelerate trial execution by enabling organizations to quickly assess trial status, identify site issues, and take necessary corrective actions to meet critical study milestones, thereby facilitating faster, informed decision-making and speeding up product time-to-market.

Key Takeaways:

• Addressing Clinical Trial Complexity: The primary driver for the Veeva Vault Clinical Suite is the exponential complexity of managing global clinical trials, which traditionally requires reliance on numerous siloed systems for documentation, data collection, milestone tracking, and compliance reporting.
• Unification of Core Clinical Functions: The solution integrates three critical applications—CTMS (Clinical Trial Management System), eTMF (electronic Trial Master File), and Study Startup—into one cohesive platform, streamlining processes that were previously managed separately across multiple systems.
• Single Source of Truth: By consolidating data and content management, the suite establishes a unified system that serves as the single source of truth for all trial information, eliminating the need to reconcile information across disparate spreadsheets, emails, and legacy systems.
• Data and Content Management Synergy: The Veeva Vault platform’s unique technical capability to manage both structured data (e.g., trial activities, metrics) and unstructured content (e.g., protocols, regulatory submissions, CVs) simultaneously is the foundation for eliminating information silos in clinical operations.
• Enhanced Collaboration for Stakeholders: Sponsors, investigators, and CROs are all brought into the same system, improving communication, ensuring consistent data entry, and providing a shared, real-time view of the trial status globally.
• Accelerated Trial Execution: The ability to quickly assess trial status and identify site issues in real-time allows organizations to take immediate corrective action, which is crucial for meeting study milestones and accelerating the overall timeline for product market entry.
• Improved Investigator Efficiency: Investigators benefit from real-time updates on study changes and the ability to enter trial information only once, leveraging that data across different sites and countries, thereby reducing administrative burden and ensuring content compliance.
• Regulatory Compliance Streamlining: The integration of the eTMF component ensures that all required content is collected and maintained as current, simplifying the documentation required to prove compliance with local and global regulatory requirements (a critical factor for FDA/EMA adherence).
• Informed Decision Making: The unified view across clinical operations provides leadership with comprehensive, real-time visibility, enabling faster and more informed strategic decisions regarding trial progress and resource allocation.

Tools/Resources Mentioned

• Veeva Vault Clinical Suite: The integrated platform solution.
• CTMS (Clinical Trial Management System): Component for managing trial activities and milestones.
• eTMF (electronic Trial Master File): Component for managing essential clinical trial documentation and ensuring regulatory compliance.
• Study Startup Applications: Component for managing the initial phase of trial execution, including site activation and document collection.

Key Concepts

• Information Silos: The traditional separation of clinical trial data (activities, milestones) and content (documents, compliance files) into different, non-communicating systems, leading to inefficiency and complexity.
• Unified System: A single technology platform capable of managing all aspects of clinical operations (data, content, and workflow) simultaneously, providing a holistic view.
• Single Source of Truth (SSOT): A concept where all stakeholders rely on one definitive, consistent, and accurate data set or document repository, crucial for regulated environments like clinical trials.