Vault Clinical Operations to RIM Connection Demo

This video provides an in-depth demonstration of the Veeva Vault Clinical Operations to RIM (Regulatory Information Management) Connection, showcasing how it seamlessly links critical information and documents between these two crucial functional areas within pharmaceutical and life sciences organizations. The main purpose is to illustrate how this integration addresses the common challenge of disparate systems where clinical and regulatory teams often maintain overlapping data and documents, leading to inefficiencies and compliance risks. The presenter walks through practical examples, highlighting the automation of data entry and document uploading processes to streamline workflows and improve collaboration.

The demonstration begins by illustrating the creation of a new product family record in the Regulatory Vault. The key insight here is that this action automatically triggers the creation of the same product record in the Clinical Vault. This ensures that clinical teams have immediate access to necessary product information when identifying candidate studies, eliminating manual re-entry. The video further explains that any subsequent updates to metadata on the product record in the RIM Vault would similarly propagate to the Clinical Vault, maintaining data consistency. The progression then shifts to the clinical side, where the creation of a new clinical study and associated countries or sites within the Clinical Vault automatically duplicates this information back into the Regulatory Vault, providing regulatory teams with up-to-date study details.

Beyond data records, a significant portion of the demo focuses on automating document processes. The video shows a clinical operations person uploading a document, such as an investigator CV from a site, into the Clinical Vault, classifying it by study, country, and site. Crucially, once this document passes its quality control (QC) process and reaches an approved lifecycle state in the Clinical Vault, the Vault Connection automatically creates a cross-link to this document in the Regulatory Vault. This cross-link is presented as a PDF rendition of the source file, providing regulatory teams with immediate access to essential documents required for submissions, such as 1572 forms or investigator CVs. The system also facilitates the automatic matching of these cross-linked documents directly into regulatory content plans, notifying regulatory teams of new documents ready for filing, thereby significantly reducing manual effort and potential errors in submission preparation.

Key Takeaways:

• Automated Data Synchronization: The Veeva Vault Clinical Operations to RIM Connection automates the transfer of critical data records, such as product families and clinical study/site information, between the Regulatory Information Management (RIM) Vault and the Clinical Operations Vault.
• Elimination of Manual Data Entry: By automatically propagating data from one vault to another upon creation or update, the connection significantly reduces the need for manual data entry by different business teams, saving time and improving efficiency.
• Reduced Risk of Errors: Automating data transfer minimizes the risk of human error, such as typos or inconsistencies, that often arise from manual re-entry of the same information across multiple systems.
• Single Source of Truth: The integration ensures that a single, authoritative source of truth is maintained for both data records and documents across clinical and regulatory functions, preventing discrepancies and ensuring data integrity.
• Streamlined Regulatory Submissions: The connection directly supports regulatory compliance by automatically making clinical documents (e.g., investigator CVs) available and cross-linked in the RIM Vault once approved in the Clinical Vault, facilitating faster and more accurate submission preparation.
• Enhanced Cross-Functional Collaboration: By providing seamless access to shared data and documents, the connection fosters better collaboration between clinical and regulatory teams, allowing them to work together more quickly and effectively.
• Automated Document Cross-Linking: Approved documents in the Clinical Vault are automatically cross-linked as PDF renditions into the Regulatory Vault, providing regulatory teams with immediate access to the necessary files for their processes.
• Integration with Content Plans: Cross-linked documents can be automatically matched into regulatory content plans, streamlining the process of assembling submission packages and ensuring all required documents are accounted for.
• Proactive Notifications: The system can notify regulatory teams when new documents or data have been transferred from the clinical side, allowing them to proactively plan for filing or submission activities.
• Operational Efficiency: The overall value proposition lies in saving time for both regulatory (preparing submissions) and clinical (conducting studies) teams, leading to greater operational efficiency across the organization.

Tools/Resources Mentioned:

• Veeva Vault (specifically RIM Vault and Clinical Operations Vault)
• Veeva Vault Connections (the integration mechanism)

Key Concepts:

• Vault to Vault Connection: A feature within Veeva Vault that enables automated data and document synchronization between different Vault applications (e.g., Clinical Operations and RIM).
• Regulatory Information Management (RIM): A system used to manage all information related to regulatory submissions, product registrations, and compliance activities.
• Clinical Operations: The processes and systems involved in managing clinical trials, including study setup, site management, and document collection.
• Cross-linking: A mechanism within Veeva Vault where a document in one vault is linked to another vault, typically as a rendition (e.g., PDF), allowing access without duplicating the source file.
• Single Source of Truth: The principle that all data and documents should originate from and be maintained in one authoritative location to ensure consistency and accuracy.
• Content Plan: A structured plan within regulatory systems that outlines all documents and information required for a specific regulatory submission.

Examples/Case Studies:

• Product Family Creation: A product family named "Solflex Attacks" is created in the RIM Vault, automatically appearing in the Clinical Vault.
• Clinical Study Creation: A clinical study named "SOL5959" is created in the Clinical Vault, automatically appearing in the RIM Vault.
• Document Upload and Cross-linking: An investigator CV for "Dr. Smith" is uploaded and approved in the Clinical Vault, automatically creating a cross-link in the Regulatory Vault for submission purposes.