Why a Site-centric Approach is Key to Your Remote Monitoring Strategy

This video provides an in-depth exploration of the critical importance of adopting a site-centric approach to remote monitoring strategies in clinical trials. The speaker, Bree Burks from Veeva Systems, draws on her extensive background working within research sites, particularly academic medical centers, to emphasize shifting the perspective from sponsors and Contract Research Organizations (CROs) to the operational realities and challenges faced by clinical research sites. The core message revolves around the need to understand site values, operational models, and technological burdens to build effective, sustainable remote monitoring solutions that truly empower sites.

Burks outlines a comprehensive framework for a site-centric approach, beginning with fundamental values such as acknowledging sites' continued critical role in decentralized and virtual trials due due to their unique patient relationships and specialized expertise. She challenges the audience to think beyond individual trial needs, urging them to consider a site's broader operational model across multiple studies and sponsors. A novel idea proposed is for sites to operate on their own technology rather than solely relying on sponsor-provided systems, fostering greater control and standardization. The presentation highlights unique challenges faced by diverse site types—including private, complex network, outpatient clinic-connected, and hospital-affiliated sites—and the pervasive issue of limited, fixed resources, especially concerning staff and budget for technology adoption and digitization efforts.

A significant portion of the discussion focuses on the "double-edged sword" of technology for sites. While past surveys (e.g., 2019) indicated site frustration with "too many systems, too many logins, too much training, and data duplication," more recent data (from the Society for Clinical Research Sites) shows a strong desire for specific technologies like e-consent, telemedicine, and e-source to enable virtual operations and reduce administrative burden. The speaker traces the evolution of site technology from early Electronic Data Capture (EDC) systems to internal business management tools, illustrating how the proliferation of disconnected systems has created significant tension. This historical context leads to the vision of a "connected and unified clinical trial ecosystem," where technology solutions are standardized, flexible, affordable, patient-centric, and supported by dedicated technology partners.

The video further delves into the practical system components of remote monitoring, stressing the need for purpose-built solutions over ad-hoc tools. Key considerations include affordability, robust security (managing logins, audit trails, handling unredacted Protected Health Information, or PHI), and the ability to provide certified copies of source documents to avoid redundant monitoring. Beyond mere access, a truly site-centric system should facilitate collaborative review, track document stages, prevent re-monitoring, and integrate seamlessly into a site's workflow. The speaker also underscores the importance of change management, including guidance on global regulations, onboarding, training, templates, and Standard Operating Procedures (SOPs), alongside community and networking support from technology providers. The future vision emphasizes unified internal systems (e.g., Clinical Trial Management Systems or CTMS, e-consent, clinical systems) and connected external systems through digital exchange mechanisms, moving towards real-time collaboration across all stakeholders, with technology partners bearing the burden of efficient data and document exchange.

Key Takeaways:

• Embrace a Site-Centric Mindset: Successful remote monitoring strategies must originate from understanding and addressing the unique perspectives, challenges, and operational realities of clinical research sites, rather than solely from sponsor/CRO needs. This foundational shift is crucial for developing effective and sustainable solutions.
• Sites Remain Critical in Decentralized Trials: Despite the rise of virtual and hybrid trials, sites provide invaluable expertise and are a critical link to patients, offering unique relationships and skills. Their continued integration and empowerment with appropriate technology are essential for the future of clinical research.
• Acknowledge Sites' Multi-Trial Operations: Clinical research sites manage numerous trials concurrently, often for different sponsors and CROs. Solutions should aim for standardization and flexibility across studies, rather than imposing unique, disparate processes for each trial, to significantly reduce operational burden and improve efficiency.
• Consider Site-Owned Technology: Exploring models where sites own and control their remote monitoring technology can allow for greater standardization across their entire portfolio of studies and reduce reliance on a multitude of disparate sponsor-provided systems. This approach, however, requires careful consideration of affordability and the maintenance burden on sites.
• Address the "Technology Overload" Paradox: While sites express frustration with "too many systems" (leading to excessive logins, training, and data duplication), they simultaneously demand specific technologies (e-consent, telemedicine, e-source) that enable virtual operations and reduce administrative tasks. Solutions must strike a delicate balance, providing needed functionality without adding to the existing system sprawl.
• Prioritize Unified and Connected Ecosystems: The future of clinical trials lies in a unified and connected ecosystem where site-level systems (e.g., CTMS, e-consent, clinical systems) are integrated internally and seamlessly connected with sponsor/CRO systems through digital exchange mechanisms. This minimizes manual data transfer, reduces duplication, and enables real-time collaboration.
• Purpose-Built Systems are Superior: Ad-hoc tools are insufficient for robust remote monitoring. Purpose-built systems offer critical features like auto-notifications, dashboards for workflow prioritization, secure audit trails, and the ability to track collaborative review processes, which prevent re-monitoring and significantly improve overall efficiency and data integrity.
• Ensure Security and Regulatory Compliance: Remote monitoring solutions must prioritize robust security, especially when handling unredacted Protected Health Information (PHI). They must also support the provision of certified copies of source documents to satisfy regulatory requirements and avoid the need for redundant on-site monitoring, streamlining the inspection process.
• Beyond Technology: Focus on Change Management: Implementing remote monitoring solutions at sites involves significant change management. Technology providers must offer comprehensive support, including guidance on global regulations, thorough onboarding, effective training, standardized templates, and clear Standard Operating Procedures (SOPs), alongside fostering community and networking opportunities.
• Affordability and Resource Burden are Key: When considering site-owned technology or new systems, the cost and resource burden (e.g., staff time, validation efforts) on sites must be a primary consideration. Solutions should be designed to be affordable and minimize ongoing maintenance for sites, which often operate with limited fixed resources.
• Prioritize Patient Centricity: Technology solutions, such as e-consent, must be designed to ensure a positive and intuitive patient experience, as sites are directly responsible for managing these patient relationships. A poor patient experience directly impacts site workload, patient retention, and overall satisfaction.
• Seek Strategic Technology Partners: Sites need technology partners who offer a clear long-term vision, provide opportunities for input on product roadmaps, and are actively engaged in professional organizations that support sites. This ensures that the solutions evolve in alignment with their strategic needs and industry best practices.

Key Concepts:

• Site-Centricity: An approach to clinical trial design and technology implementation that prioritizes the operational needs, challenges, and perspectives of clinical research sites.
• Remote Monitoring: The process of reviewing clinical trial data and documents from a remote location, reducing the need for on-site visits by monitors.
• Unified Clinical Trial Ecosystem: A future state where all systems used by sites, sponsors, and CROs are seamlessly integrated and connected, allowing for efficient, real-time data and document exchange across the entire trial lifecycle.
• Digital Exchange Mechanism: A technological framework or platform that facilitates the secure and efficient sharing of information and documents between different stakeholders (e.g., sites, sponsors, CROs) without manual intervention.
• Certified Copies: Electronically generated copies of original source documents that are verified as true and accurate representations of the original, meeting regulatory requirements for inspectable records.
• E-consent: Electronic informed consent, allowing patients to review and sign consent forms digitally.
• E-source: Electronic source data, where patient data is captured directly into an electronic system at the source, eliminating paper records.
• CTMS (Clinical Trial Management System): A software system used by clinical research organizations and sponsors to manage and track various aspects of clinical trials, from planning and startup to closeout.

Tools/Resources Mentioned:

• Veeva Systems: The speaker's employer, a technology company providing solutions for the life sciences industry.
• EDCs (Electronic Data Capture systems): Early technology introduced to sites for data collection.
• Society for Clinical Research Sites (SCRS): An organization that conducted a survey mentioned in the presentation regarding sites' technology needs and desires.