On-site monitoring has long been a common operation during the development of clinical trials. However, recent technological developments are improving the way monitoring tasks are performed. Remote monitoring offers all parties involved in clinical research a fast and efficient avenue to solve the challenges related to clinical trial site monitoring.
What is remote monitoring in clinical trials?
Remote monitoring in clinical trials is one of the perks of implementing digital solutions during clinical trial operations. Thanks to remote study monitoring, monitors don’t have to perform physical visits to study sites and can perform fully-virtual assessments of clinical trials.
What is the purpose of clinical monitoring?
The main purpose of monitoring visits is to certify that reported trial data and all trial documentation is accurate, complete, and verifiable from source documents. Likewise, visits to clinical trial sites are performed to make sure that the rights and well-being of all study participants are protected.
Thanks to clinical monitoring, compliance with the protocol, good clinical practices, and federal and local regulations is ensured. Monitors are typically Clinical Research Associates (CRAs) appointed directly by a Sponsor or a Contact Research Organization (CRO). They are professionals with the knowledge and experience to accurately perform clinical trial monitoring activities.
The duties of a monitor are:
- To certify the qualifications of the investigator and the staff
- To confirm that all documentation is collected in an orderly manner
- To check that all source data is collected and accurately transcribed onto case report forms
- To ensure the protocol is followed
- To protect patient safety and rights, including the ethical and consensual participation of all patients
- To observe the supply of medications
- To review and gain approval for any changes made to the study plan
The different types of clinical trial monitoring
On-site monitoring
Prior to the creation of digital monitoring solutions, on-site monitoring was the only alternative available. It consists of monitors performing in-person visits to clinical trial sites. The content and duration of on-site monitoring visits vary depending on the volume of data that must be reviewed.
It is reported that over 40% of on-site monitoring efforts go into Source Data Verification (SDV) alone, and costs companies about one-third of their total phase III study budgets (source). Reviewing documentation is a second major effort. Fortunately, modern, software-driven methods of monitoring promise to bring the costs associated with these activities down while also improving the efficiency of monitoring.
Remote monitoring
During remote monitoring, tasks that are traditionally considered on-site activities are performed remotely, using shared software applications that connect the site and the monitor s. Monitoring tasks from the simplest interventional study tasks, such as medical device logs, to the overall monitoring of essential documentation and SDV can be performed using the latest remote monitoring software.
A clinical trial conducted from multiple sites benefits greatly from remote monitoring. Likewise, research has proven that risk-based monitoring is improved by remote solutions. When studying the benefits of a remote risk-based approach to monitoring, it was proven that remote monitoring improves effectiveness while saving travel time and monitoring costs. (source)
Centralized monitoring
This method involves analytical evaluation carried out at a central location instead of clinical trial sites. It is easy to confuse on-site monitoring with a centralized approach. However, centralized monitoring means that monitoring tasks are performed from a single location and the data itself may come from on-site monitoring as well as remote monitoring solutions.
Benefits of remote clinical trial monitoring
Complete and secure remote site access
When a Sponsor and a clinical trial site are digitally connected, monitors gain secure access to the site’s remote trial documentation. Moreover, information can be accessed from anywhere and anytime. Sites can grant Sponsors and CRO monitors user-based permissions to all the data relevant to their tasks.
Remote access allows monitors to fulfill their assignments swiftly and comfortably, avoiding travel costs, on-site restrictions, and other challenges posed by on-site monitoring. This translates into companies being able to save time and money while also speeding up the time it takes for research to be completed.
Enhanced communication and collaboration capabilities
Remote monitoring systems act as a powerful hub for collaboration and communication between the sites and the Sponsor. Features found on modern eISF software include intuitive dashboards, notifications, in-app messages, and more. Thanks to these digital capabilities, communication delays become a thing of the past. This becomes particularly useful if one considers that correspondence data is required for a compliant ISF.
Improve CRO and Sponsor Collaboration with a Shared eTMF
Comprehensive tracking of ongoing clinical trials
When remote monitoring is performed via a technology platform, one is able to track site performance and study progress in real-time. Moreover, no site staff assistance is required, thus allowing site personnel to continue their duties unobstructed. Site efficiency, study timelines, document completion, and other pieces of critical information can be directly accessed via the system’s dashboard. By setting up system alerts and notifications, monitors can track progress and site activity without the need to personally check for updates.
Improved compliance
Remote monitoring platforms are designed by industry experts to create a fully-compliant research environment. Not only are all regulatory standards taken into consideration, but the software also keeps clear audit trails to facilitate all kinds of inspections.
Automatic management of clinical trials data
Remote clinical trial monitoring platforms allow accessing and reviewing documents in real-time, avoiding issues such as duplicate work being created or staff working with outdated information. Moreover, an integrated eISF platform can directly connect to a Sponsor’s eTMF to automatically route Quality Controlled documents, track electronic signatures, capture data, and perform other syncing tasks.
Creating a high-quality process and workflow standard
While paper-based monitoring methods limit the efficiency of repeatable processes, these can be easily executed and duplicated with technology-driven solutions. Automation allows for the quick creation of standardized folder and binder structures. Effective processes can also be repurposed for use in other sites and in future studies.
Benefits of electronic document management in Pharma
How to prepare for remote clinical trial monitoring
All clinical research organizations must perform periodic monitoring tasks. Thus, it is extremely important to always be ready for data monitoring activities.
Ensuring a research site is ready for remote clinical trial monitoring
To make sure a research site is equipped for effective remote clinical monitoring:
- Sponsors and monitors must be able to access eRegulatory files, as well as redacted source files and logs.
- Sponsors should be able to review and quality control all documentation, such as medical records, in real-time.
- Documents should be synced with a Sponsor’s electronic Trial Master File (eTMF).
- Clinical trial sites must be able to capture source documents in a single environment. This is achieved via integrated and encrypted source collection points like EMR/EHR or CTMS.
Regardless of a site’s level of digital sophistication, its technology infrastructure should be able to support the performance of remote clinical trial monitoring. There are two main paths to ascertain efficient remote monitoring capabilities: Using sponsor-driven technology or a site-procured remote clinical monitoring and eISF solution. Nowadays, the latter option is gaining traction in modern clinical trial sites.
Sponsor-driven clinical trial monitoring
Using a Sponsor-driven solution can present certain challenges to clinical trial sites. It is essential for sites to guarantee that a Sponsor’s solution aligns with their own needs and workflows.
When making a decision, site administrators should consider the following:
- Will a Sponsor’s solution integrate with established site workflows? If a Sponsor-driven solution doesn’t seamlessly connect to the site’s established workflows, it may come into conflict with organizational-wide processes.
- Who will have ownership of clinical trial data and documents? Having control over an eISF ensures compliance with regulatory standards. It is important to know who will be responsible for data flow and ownership to uphold ICH and CGP standards.
- Will the site be able to control access and permissions? Monitors should have access to the data that is relevant to them. Likewise, it is necessary to keep clean and clear audit trails. If sites can’t control what documents and sources are available, that may put critical data at risk.
- Can the solution be upscaled to work beyond a single clinical study? It is in the best interest of sites to be able to replicate efficient processes and workflows. Thereby, having access to tools that can be used for several studies works to a site’s advantage.
- Will the solution work towards the improvement of research site operations? Sites should consider that any technology they implement can be either a benefit or a hindrance. A sponsor’s solution may be working against a site’s best interests.
Site-procured clinical trial monitoring
A site-procured eISF solution gives sites improved remote monitoring and management capacities. Sponsors can be easily given access to eISF contents, while sites don’t have to contend with any unforeseen challenges caused by Sponsor-driven systems.
eISF technology offers clinical trial sites the following immediate benefits:
- The consolidation of studies (or several sites) for monitoring
- The creation of repeatable effective processes
- Control over the narrative with external stakeholders
- Future-proofing the site’s operations as technology evolves
- The improvement of workflows
- Limiting disruptive on-site exposure to monitors
Meanwhile, site-procured eISF benefits Sponsors in the following ways:
- Cost and time-effective remote monitoring
- The acquisition of efficient technology that easily integrates with other systems
- Real-time access to relevant information
- Eliminating the need to collect documents from various sources (paper, email, and FTP portals)
- Tracking productivity and progress via intuitive reporting tools
- A secure digital environment that avoids compliance risks
Choosing a remote clinical trial monitoring path
Remote monitoring is clearly here to stay. To take advantge of this change, sponsors, CROs and sites need to invest in digital tools for effective monitoring. If you’re looking for an ideal platform with both remote monitoring and eISF capabilities, then Agatha has what you need.
Agatha Remote ISF offers state-of-the-art remote monitoring capabilities and much more. The platform can act as a powerful hub for communication and collaboration between the different parties involved in clinical research. Thanks to Agatha Remote ISF, information can be standardized across several clinical trial sites, improving the quality of research while also reducing costs.