The COVID-19 pandemic has accelerated the ongoing shift to remote clinical trial monitoring. Remote site access and monitoring platforms are now an essential element of the clinical trial process and a vital connection between the sponsor, clinical research organization (CRO), and the research site.

The sponsor or CRO must ensure that the research site conducts the trial per the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and any other regulatory requirements.

To oversee these activities, sponsors/CROs historically have monitored sites by sending information through email, fax, or online portals; and holding on-site monitoring visits.

Ultimately, when conducting an IND trial, regulations require the sponsor/CRO to guarantee the:

• Rights and safety of patients are protected
• Reported trial data is accurate, complete, and verifiable from source documents
• Conduct of the trial is compliant with the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements

Although the FDA suggested shifting to remote monitoring in 2013, the industry has been slow to adopt remote monitoring technology until the COVID-19 pandemic made traditional monitoring impossible. To explore FDA guidance for remote site access and COVID-19, please visit this resource.

In this article we explore:

• Challenges of Traditional Monitoring
• Benefits of Remote Clinical Trial Monitoring
• How to Deploy Remote Clinical Trial Monitoring 
• Sponsor-Deployed Remote Monitoring Technology
• Site-Procured Remote Monitoring Technology

For an in-depth eBook on this information download the Complete Guide to eISF + Remote Site Access.

Challenges of Traditional Monitoring Processes

Historically, on-site monitoring visits were a critical component throughout the entire lifecycle of a study, from site selection through study close-out.

However, as both the complexity of clinical trials and demand for remote site connectivity is increasing, research organizations are looking for solutions to lower cost and remove inefficient workflows.

Now, with COVID-19 restrictions, this search for remote clinical trial monitoring solutions has surged.

Increasing Number and Complexity of Trials

According to ClinicalTrials.gov, the number of registered trials have almost doubled from 181,238 trials in 2015 to 325,817 trials in 2020. The studies aren’t just growing in number; they are growing in complexity.

Monitors and Clinical Research Associates tasked with clinical trial monitoring face increasing pressure from regulatory demands requiring near real-time site oversight and sponsor expectations for more timely data exchange.

Coupling this with larger data sets and study loads causes additional strain on traditional monitoring tactics that result in slower study progression and potentially timely delays.

Obstacles to Site Access and Connectivity

The demand for digital site connectivity has been growing over the past decade. Both sites and sponsors expect over fifty percent of all tasks to be completed digitally by 2023.

And that was before COVID-19, which has increased the need for digital solutions due to on-site restrictions, travel bans, and increased safety precautions for site staff and monitors.

In the past, software vendors serving the sponsor/CRO market have tried to fill this need by deploying “sponsor-first” software platforms, known as “site-portals” to research sites. These platforms have been slow to gain site acceptance as they burden sites with additional workload, disjointed processes, and numerous portal logins for various sponsors.

Benefits of Remote Clinical Trial Monitoring

Purpose-built systems that support remote clinical trial monitoring create cross-organizational efficiencies when the technology vendor considers both sites and sponsors’ workflow needs.

Instead of pushing out a “site-portal” to research sites, sponsors and CROs are now meeting sites’ needs in two ways: by integrating with the site’s current technology infrastructure or by deploying an Electronic Investigator Site File (eISF) system that can connect to the sponsor’s Electronic Trial Master File (eTMF).

By building a digital network that enables remote clinical trial monitoring, both sites and sponsors can capture the following benefits: 

Improve and Complete Remote Site Access

By digitally connecting sponsor and site systems, the monitor can securely access the research site’s trial documentation from anywhere and anytime. Sponsors and CRO monitors receive user-based permissions to the studies and sites that they need to manage. This access allows monitors to complete their work remotely without communication, onsite restriction, or travel delays, saving significant time, and reducing overall cost.

Efficient Communication Between Site and Sponsor

Most technology systems that enable remote monitoring also include features that allow for streamlined communication like notifications, dashboards, in-app messaging, and email push-notifications. These features reduce communication delays from antiquated processes and consolidate all conversations where the work gets done – in the technology system itself.

Comprehensive Tracking of Site and Study Progress

When clinical trials are transitioned out of paper and into technology platforms, site performance and study progress can be tracked in real-time without site staff assistance. Monitors can typically set up system alerts and notifications for document completion and other site activity, eliminating wasted time communicating or checking for updates. Dashboards create a singular view of site efficiency, study timelines, document completion, and outstanding actions to manage trial activities more effectively.

Compliant Processes and Oversight

Compliant technology that complies with 21 CFR Part 11 and HIPAA standards creates a secure environment to complete and manage clinical trial documents and data. Source documents can be reviewed remotely. Audit trails offer a clear path to track compliance and staff actions.

Automatic Document Routing Within and Between Systems

The fear of creating duplicate work has often been an issue for sites, sponsors, and CROs looking to adopt new technology. Fortunately, purpose-built remote clinical trial monitoring platforms have identified and addressed this concern by connecting the eTMF and eISF to enable the ability to:

• • Automatically route Quality Controlled documents to the eTMF
  • Deploy one-click eTMF binder structures to all sites
  • Assign and track electronic signatures
  • Redact, edit and capture data
  • Update versions of documents in a single place

Standardize Repeatable Processes and Workflows

The paper-based methods used in traditional monitoring limit the ability for repeatable processes to be made more efficient.. In contrast, with technology driving these repeatable workflows, they can be built into a process once and executed or duplicated in a few clicks. Standardized folder and binder structures can be created in a central folder and duplicated across studies or sites. Document templates for 1572’s or training can also be stored in a central location and utilized to streamline efforts.

Preparing for Remote Clinical Trial Monitoring

Knowing that remote clinical trial monitoring is here to stay and both sites and sponsors need a solution in place, the question becomes: is your research site equipped to participate in this transformation? 

There are four ways to ensure your research site is equipped for remote clinical trial monitoring:

1. Sponsors and monitors can access eRegulatory files, redacted source files, and logs. 
2. Sponsors can review and quality control documents in the platform in real-time.
3. Sponsors can sync documents back to their Electronic Trial Master File (eTMF).
4. Sites can digitally capture source documents in one environment via integrated and encrypted source collection points (EMR/EHR, CTMS, etc.)

Two Paths to Remote Clinical Trial Monitoring

A site’s technology infrastructure is key to making remote clinical trial monitoring and remote site access work. We’ve identified two paths to remote monitoring regardless of your research site’s level of technology sophistication. 

The first path is one many research sites are familiar with: a sponsor-driven and sponsor-deployed technology.

The second path has emerged over the past four years as sites have built out their infrastructure: a site-procured and site-maintained remote clinical trial monitoring and eISF solution. The industry is shifting to path 2 (site-procured), but some sites are not ready to pursue this step.

As we look at both paths, we will identify specific solutions associated with each and the benefits of those solutions.

We will also explore how in Path 1 sponsors have a new solution available to deploy to research sites that takes a fresh approach to what sponsors have always done historically, and that is putting the research site at the forefront of the technology.

Path 1: Sponsor Deployed

If you are a research site, you have a choice to agree to use a sponsor-deployed solution. Before you make this commitment, it is essential to ask some basic questions to ensure that the sponsor-driven solution and the solution’s vendor aligns with your needs and workflows.

Questions to ask:

   Will this solution integrate with existing established site workflows? Integration with your established site workflows ensures you are not in conflict with your organizational-wide processes.

   Will you own the data and documents? Maintaining control of your eISF and its components is key to being compliant and upholding ICH GCP standards. Will this solution help you do that? What about the data flowing through it? Is that data owned by the site or the sponsor?

   Do you as the site control access and permissions? Monitors should only see certain documents and sources during certain times. Are you able to easily control that?

   Will the solution vendor help us be successful? Training and ongoing support are essential to set sites up for success. Are you expected to learn the solution yourself or will the vendor provide training to help you get started? Will the solution provide ongoing support throughout the life of the study?

   Is there a path to expand my team’s usage beyond a singular study? Replicating efficient processes and workflows saves time.  Is there an opportunity to use the tool’s capabilities for other studies? 

   Does the solution focus on the success of the research site? A site-first technology tool serves the site and facilitates efficiency for the study as a whole.

By asking these questions, you are in a position to drive for better sponsor-driven technology. 

Over the years, there has been an evolution of sponsor-deployed site access and remote clinical trial monitoring capabilities including:

• FTP/Upload Portals: Sponsor provides a portal and sites upload all documents for review. This workflow provides no long-term benefit for the site because it limits the site’s control of documents, processes, and audit trails. The site is also unable to expand to site-wide workflows.
• Document Vaults: Sponsor requests that sites manage some of their documents in the vault and the sponsors can access it remotely. This workflow is challenging to roll out, burdensome to sites, and limits the site’s control as it’s a sponsor-first tool. 
• Site managed eISF Platform: In the Florence version of this model, the sponsor partners with Florence to deliver a site and sponsor collaborative electronic investigator site file (eISF) that enables remote monitoring and supports Remote Source Access (RSA). Study sites maintain their own eISF space tailored by the sponsor in partnership with Florence so study sites can maintain ownership of their documents and data, while collaborating with study partners, including ongoing monitoring. Sites can expand their usage across their organization and for other studies and are remote ready for future sponsor-driven opportunities. 

A site managed Electronic Investigator Site File (eISF) Platform with remote monitoring capabilities is a beneficial choice for both sites and sponsors. With this solution, all stakeholders have clear wins to becoming technology-enabled and remote monitoring ready. 

Path 2: Site Procured

The second path is a site-procured solution for remote monitoring and eISF management. In this path, you are solving the sponsor’s problem by giving them access to your eISF and providing remote monitoring capabilities.

Because remote monitoring and remote Source Data Verification (SDV) strategy benefit both sites and sponsors, from our experience, sponsors will financially support this model because of the following system benefits:

• Remote Monitoring: Fulfills the current need and helps the sponsor adopt a new remote strategy that is more efficient and saves money.
• Site Process: Integrates with existing workflows for enhanced productivity around existing internal processes.
• Real-time Access: Strengthens site oversight and transparency.
• Virtual Document Exchange/Collaboration: Eliminates the need for repetitive steps associated with collecting documents via physical paper, email, or FTP Portals.
• Reporting and Dashboards: Tracks site productivity and progress, gain insights into bottlenecks, and facilitates future site selection based on historical efficiency.
• Compliance: Avoids compliance risks with a secure environment for monitoring and streamlined processes around eRegulatory document and data management and information exchange.

With the right remote monitoring and eISF solution in place, there are key benefits for both sites and sponsors or CROs. The site-procured technology also creates the opportunity for you to use a single platform across all of your studies, sites participating in multicenter trials, sponsors, and CROs.

Choose your Remote Clinical Trial Monitoring Path

How can you choose the right solution? It’s not just about the basic ability to achieve remote monitoring - it’s about the long-term impact. The core technology infrastructure you  create will affect how future-proof your study processes are and how likely you are to meet evolving sponsor goals. 

To ensure you select a platform that provides you optimal success be sure that you complete this eISF + Remote Monitoring Checklist: 

✓Encrypted Source Capture & PHI Flag + Redaction
✓Role-Based Access Controls
✓QC/Monitoring Collaboration Module
✓Role-Based Vendor Supported Training
✓Integration Capabilities – SIP, eTMF, large sponsor systems
✓Compliant Audit Trails  

Remote monitoring is here to stay and you are in a position of strength to drive the decision based on your needs and the evolving benefits for your study partners. The key takeaway is to ensure that the solution you choose to work with, is one that is centered on the study site’s workflows and unique needs. Sponsors and CROs are eager to collaborate and regain critical access to a study site’s documents and source data, so now is a great time to drive this conversation.

Accelerate Clinical Trial Timelines and Advance Cures

As the industry realizes the benefits of remote clinical trial monitoring, sites and sponsors are accelerating their technology adoption to meet the demands for site access, and the rising number of complex clinical trials.

The main goal of enabling remote clinical trial monitoring is to reduce trial costs, accelerate clinical trial timelines, reduce study start-up, and advance cures. Due to COVID, the industry is adopting technology faster, and it's essential to decide how your organization is moving forward in 2021.

To take the next steps for your organization:

• Sponsors or CROs should explore the Complete Guide to the eISF + Remote Site Access, which was designed to educate the industry on selecting technology and integrating with existing site infrastructures or deploying your own solution to sites.
• Sites should explore the Complete Guide to eRegulatory and eSource, which outlines the benefits of eRegulatory technology for sites and how this technology enables remote clinical trial monitoring.