Manages Multiple Research Sites With Ease On Veeva eISF

This video provides an in-depth testimonial regarding the transformative impact of adopting an electronic Investigator Site File (eISF), specifically Veeva SiteVault, for managing multi-site clinical research operations. Alisha Garibaldi of Skylight Health Research, Inc., details her experience overseeing three distinct research locations in the US, highlighting the critical role the eISF played in maintaining operational continuity and efficiency, particularly through a challenging year (2023). The core message emphasizes that the implementation of the eISF was not merely an upgrade but a fundamental change that simplified complex, multi-location research management, moving documentation and monitoring processes into a centralized digital environment.

The speaker manages a diverse set of research sites, including two standalone facilities (Burlington and Colorado Springs) and one site integrated with a primary and urgent care clinic (Harrisburg, PA). This heterogeneity underscores the challenge of standardizing processes across different operational models. The adoption of the eISF centralized all documentation, ensuring that "everything now automatically goes on to Veeva." This centralization is crucial for maintaining consistency and control across geographically dispersed and structurally different research environments, a common pain point for growing Contract Research Organizations (CROs) and site networks.

A significant benefit highlighted is the improvement in regulatory compliance and monitoring efficiency. By granting monitors access to the eISF remotely, the system effectively keeps them "out of my clinics," which streamlines site operations and reduces disruption to patient care and staff workflow. This capability proved invaluable during a recent site audit. The speaker noted that the auditor explicitly mentioned that having all documentation readily available on Veeva made her life "so much easier." This anecdote confirms the system's utility in simplifying audit readiness and execution, a key metric for regulatory success in clinical trials. Furthermore, the ability to upload paper source documents as certified copies to Veeva allows for quick corrections and maintenance of the official trial record.

Operationally, the eISF enables sophisticated resource management, particularly concerning remote staffing. The speaker leverages the digital platform to onboard and utilize remote staff from various locations for a single trial. This flexibility allows the organization to allocate resources where they are most needed—for instance, having remote staff assist a busy site with uploading source documents, data entry, and resolving queries. This strategic use of remote support ensures that on-site staff can focus exclusively on patient care and core research activities, maximizing efficiency and minimizing bottlenecks caused by administrative tasks. The overall implementation fundamentally changed how the organization approaches documentation, monitoring, and staff deployment across its multi-site network.

Key Takeaways: • eISF is Essential for Multi-Site Management: The speaker asserts that managing three geographically disparate research sites would have been nearly impossible without the implementation of an eISF, underscoring its role as foundational technology for scaling clinical research operations. • Centralization Drives Consistency: Moving all documentation to a centralized eISF ensures process standardization across sites with varied operational structures (standalone research vs. integrated clinic models), which is critical for maintaining data integrity and regulatory adherence. • Remote Monitoring Reduces Site Burden: Utilizing the eISF for remote monitor access significantly reduces the physical presence of monitors in clinics, minimizing operational disruption and allowing site staff to focus on patient-facing and core research activities. • Audit Readiness is Enhanced: The platform dramatically simplifies the audit process; the auditor’s positive feedback confirms that centralized, easily accessible digital documentation accelerates review times and improves the overall audit experience. • Leveraging Certified Copies: The workflow involves uploading Paper Source documents as certified copies directly into the Veeva system, which is a compliant method for digitizing essential trial records and facilitating immediate access for review and correction. • Enabling Remote Staffing Flexibility: The eISF facilitates a flexible staffing model, allowing organizations to onboard and utilize remote staff across multiple locations to assist with administrative tasks like source document uploading, data entry, and query resolution. • Focusing On-Site Staff on Core Tasks: By offloading administrative duties to remote staff via the eISF, the technology ensures that on-the-ground personnel can dedicate their time and attention to patient recruitment, care, and complex clinical procedures. • Operational Transformation: The implementation of the eISF resulted in a complete change in operational procedures across all three sites, moving beyond simple digitization to a fully integrated digital workflow for clinical trial management. • Value of Integrated Regulatory Technology: The experience highlights the direct correlation between adopting regulated enterprise software (like Veeva SiteVault) and achieving demonstrable improvements in compliance, efficiency, and audit performance. • Need for Digital Correction Capabilities: The ability to make "quick corrections when we need to" is a vital feature of the digital system, ensuring that documentation remains accurate and up-to-date in real-time, which is challenging to achieve with purely paper-based systems.

Tools/Resources Mentioned:

• Veeva eISF (Electronic Investigator Site File)
• Veeva SiteVault (The platform hosting the eISF)

Key Concepts:

• eISF (Electronic Investigator Site File): A digital system used to manage and store all essential regulatory and operational documents required for a clinical trial site, replacing traditional paper binders.
• Certified Copy: A process where a digital copy of a paper source document is verified and authenticated to serve as the official, regulatory-compliant record within the electronic system.
• Remote Monitoring: The practice of clinical research associates (CRAs) reviewing trial documentation and data remotely via a digital platform, rather than conducting all monitoring visits physically at the research site.
• Multi-Site Management: The operational challenge of overseeing and standardizing processes, documentation, and compliance across multiple physically separate clinical research locations.

Examples/Case Studies:

• Skylight Health Research, Inc. Multi-Site Network: The speaker manages three distinct US locations (Burlington, CO Springs, Harrisburg, PA), demonstrating the system's utility in managing both standalone research sites and sites integrated within existing primary/urgent care clinics.
• Successful Audit Experience: The site underwent an audit where the auditor specifically noted that the centralized documentation within Veeva significantly eased and accelerated the review process, validating the system's regulatory benefits.