Remote clinical trial monitoring (CTM) is becoming the new standard & is taking on an increasingly important role in healthcare. Remote CTM is the use of systems of care to help identify, monitor, and report on the effectiveness of clinical trials of new drugs, medical devices, and other interventions. Improvements in the technology behind remote monitoring has lead to wider adoption of this type of research.
With the cost of new products on the rise, it’s becoming more important than ever to ensure that the clinical trials that are conducted to evaluate safety or efficacy are properly monitored.
In this post, we’ll discuss why remote clinical trial monitoring is the new standard in the healthcare industry. We’ll also examine the key features of remote clinical trial monitoring and how they can benefit your clinical trials.
The 3 Types of Clinical Monitoring
As clinical trial techniques become more complex, there is a confusion that holds on, which is the understanding of remote monitoring against centralized monitoring. Here are the definitions of the types of clinical monitoring.
It is an in-person evaluation handled by sponsor personnel or agents at the clinical investigation site.
The evaluation happens away from the investigation site, and a monitor performs the off-site assessment.
Centralized monitoring entails systematic assessment handled by sponsor personnel or agents at a central site other than the location where the clinical monitoring is happening.
Benefits of Remote Monitoring for Clinical Trials
Systems designed and built to support remote monitoring may offer the necessary enhancements like lower costs, increased efficiency and improve the needs of sites, Contract Research Organizations, and sponsors. The benefits that can be enjoyed by sites and sponsors using the digital platform that allows remote clinical trial monitoring include:
Improve data quality
The transition from traditional clinical trial monitoring that used paper into technology-based systems such as a LIMS allows data to be processed and tracked in real-time without the supervision of site staff. Monitors can check site performance and progress of their trials easily with technology platforms.
Remote monitoring eliminates errors that would have happened if the process was done manually and also helps to reduce compliance issues.
Systems used in remote monitoring track comprehensive conversations in a central location and automatically notifies site administrators and clinical research associates (CRAs) when someone needs feedback. That reduces the work and time taken to give a response.
Other ways remote monitoring platforms increase efficiency include:
- Step-by-step workflows – It enhances the review process of repeatable workflows by allowing monitors to review every document and provide their feedback before proceeding with the process.
- Work organization – Work and data can be organized automatically based on their type, deadline and status, allowing CRAs and administrators to prioritize their work.
- Collaboration – There is support for collaboration where CRAs can flag some terms or phrases in a document after reviewing it then send it back for clarification. Site administrators can look at the document and provide instant feedback because alerts notify them of new documents available for review.
Full remote site access
With remote monitoring, sponsor and site systems may be linked digitally. That allows a monitor to access the research data and documents of a site remotely at any time.
Sponsors and CROs are permitted to access studies and data of the sites they need to manage. They can finish their tasks without any restrictions or travel delays and work remotely, saving time and lowering the overall clinical trial costs.
Carrying out a clinical trial is usually expensive and onsite monitoring takes up a high percentage of the total costs. The high costs consist of CRA expenses like transportation, accommodation and meals when they travel. These expenses may quickly increase when issues arise, requiring the CRA to visit the site numerous times.
Challenges of Traditional Monitoring for Clinical Trials
- Increasing amount and difficulty of trials – The number of registered trials are constantly increasing and they are also becoming more complex
- Site selection and recruitment – It is difficult to recruit and maintain adequate trial participants. It is one of the leading causes of delays and clinical trial failures.
- Data management – Many companies still manage their data manually and that makes quick information update difficult. It also complicates the compilation of data from different sources and across multiple technology platforms.