Introduction
Clinical trials are expensive and time-consuming when they are performed onsite. To overcome these situations, clinical professionals prefer remote monitoring over the onsite monitoring process. Remote monitoring process was not much in trend before covid-19 pandemic but, this pandemic situation has accelerated the ongoing shift from onsite monitoring to remote monitoring. Remote monitoring is beneficial for both patients to participate in trials and clinicians to monitor in real-time.
Before going deep into the topic and talking more about RMP importance, we would like to talk a bit about challenges in the onsite monitoring process.
Significant challenges of traditional monitoring process
The scenario of clinical research studies has become complex due to ever increasing demands of regulatory compliance, deadlines, increasing costs of conducting clinical trials, patient availability, etc. All of these issues can be resolved through technological involvement, i.e., remote monitoring process (RMP), where patients and clinicians get digitally connected for the assessments, and research organizations can reduce the rising cost and manage deadlines better. Additionally, RMP ensures all regulatory compliances and patient safety.
In the on-site monitoring process, physical visit is a vital component throughout the lifecycle of a research study, which increases the complexity of the clinical trials. But regulatory affairs and sponsors demand more real-time site reports from clinical associates.Furthermore, clinicians face challenges in handling large amounts of data following the traditional monitoring tactics, and the consequences are slower study progression and reporting-delays.
Therefore, research organizations are looking for alternative solutions to cope with the increasing demand for real-time data reports, and timely data exchange.
What is the remote monitoring process & how does it work in clinical research?
Remote monitoring is a new approach where clinicians, researchers track and assess their study progress remotely in-realtime and this makes their job simpler. Remote monitoring process allows researchers to save all necessary documents, labs histories in a secured online workspace and all these crucial data can be easily accessed by researchers when required.
Remote monitoring is not only convenient for clinical professionals, but also for patients who have enrolled their name in clinical trials. It saves travel-time & expenses. They are allowed to be participated and monitored from their known environment.
Some clinicians stated that the remote monitoring process allows more diverse patient-population in a clinical study and allows them to track subtle clinical changes location-wise. Furthermore, clinicians can also consider multiple factors such as race, sex, genetics, environmental factors in their research study. RMP also reduces patient burden as there will be fewer visits required, and also a good option for candidates who have mobility issues, travel concerns, and chronic illness.
Importance of remote monitoring in clinical studies & its benefits
By creating a digital network, remote monitoring process allows therapists and clinicians to enjoy the following benefits:
Provide complete remote site access to researchers:
Remote monitoring allows researchers to access necessary sites from any location any time with the involvement of RMP. Researchers receive user-based permission to access sites that they need to manage and monitor. This accessibility helps them to complete and manage their task remotely with virtual communication. With Remote monitoring researchers can overcome onsite restrictions, travel delay, save significant amounts of time, and save overall expenses for the overall clinical study.
Make communication more effective:
Remote monitoring is generally featured with advanced technologies that help to improve communication. New tech comes with multiple options of communication like email push-notification, in-app notification, dedicated dashboards to keep everyone on the same page. All these features work together to reduce communication delays, and consolidate all conversations.
Help researchers to track site-performance & study progress
When clinical trials of any research study transition out from paper to digitally connected platforms, researchers can monitor site performance and study progress in real-time without doing much paperwork, manual error, and without staff-assistance. RMP comes with a dashboard to check site-efficiency, document completion, study timelines that usually help clinicians to handle trial activities more efficiently.
Remote monitoring integrated with compliant technology
Meeting compliance according to the rules and regulations of each country can be challenging. However, the remote monitoring process (RMP) is linked with compliant technology, and fulfills HIPAA standards. Both of these allow clinicians to manage clinical trial documents and data remotely.
Standardize repeatable workflow
In the traditional monitoring process, researchers have to do a lot of paper-work for a single clinical trial, which is undoubtedly repeatable and time-consuming. In contrast, remote monitoring processes standardize this repeatable workflow with the help of digital technology and enables duplicating the complete workflow in just a few clicks. Hence, it saves lots of time and efforts of researchers. RMP also allows researchers to create standardized folder and binder structure in a central folder; and then duplicate them across different studies or sites when required.
RMP reduces the occurrence of patient dropout
Patient recruitment is a tiresome process for any clinical trial. In most of the cases, patient’s dropout because of travel inconveniences, or time-availability issues; Therefore, researchers face problems in completing their clinical trials. However, remote based monitoring increases the availability of the patients, and reduces the occurrence of patient dropout. Patients can participate in clinical studies from their place and can be monitored by clinicians from time to time.
Time saving & cost-effective
Onsite clinical studies are undoubtedly costly and time consuming which may sometimes cause budget-issue, or researchers have to complete clinical trials in stipulated time-frame. In these cases, the remote monitoring process is a boon in the research field. Some of the clinical studies are performed in a hybrid model (Onsite + RMP) as per the clinicians’ and patients’ convenience to complete a research study successfully without crossing allocated budget and time as well for the project.
Application of Squegg in remote monitoring process ( RMP)
Remote monitoring in clinical trials means monitors don’t need to visit the site to transfer and review the data. Instead, the data monitoring is done virtually. With the use of digital technology, Contract Research Organizations ( CROs) and research sponsors/ stakeholders can check necessary data from any location . Squegg device is qualified for the remote monitoring process. Squegg is a bluetooth enabled digital dynamometer that helps therapists to evaluate, monitor improvements of their patients’ grip strength.It supports real-time monitoring & real-world data in remote clinical trials. It means hand therapists can run clinical trials remotely as well as collect data from patients using Squegg. Squegg makes the data collection and monitoring process super-convenient for hand therapists and provides researchers with better insights.