Episode Notes
We are thrilled to have Robert Taylor, Associate Director of Clinical Operations at Innovaderm, join us. Robert has an extensive background, having served in various roles such as coordinator, clinical research associate (CRA), Clinical Trial Manager, and Project Manager at small contract research organizations (CROs). Currently, he is pursuing his Lean Six Sigma Green Belt certification and has an impressive track record of over 25 publications, primarily focused on pain clinical trials. He has also presented at major conferences, sharing his valuable insights.
In this episode, Robert will share his expertise on improving clinical trial efficiency with clinical trial management system (CTMS) for Sponsors, CROs, and sites. We will explore 3 key areas:
- Centralized Data Management
- Process Automation
- Remote Monitoring Tools
The Transformative Impact of CTMS on Clinical Trials
In terms of the timeline of technology, CTMS is not new to clinical research. These systems started in the early 2000s, following electronic data capture (EDC), which emerged in the early 1990s. For over 20 years, CTMS and the platforms have had significant opportunities for improvement. Currently, these much larger CTMS systems possess capabilities to perform various functions, such as pulling data from other systems like EDC. The ability to manage study communication, action items, and protocol deviations is included. Real-time updates to study data are provided through detailed reports or colorful dashboards.
The value in these systems now lies in their ability to drive down study costs and speed up trials, enabling faster opening and closing of trials. Overall study quality is improved, regulatory compliance is enhanced, and greater collaboration among all stakeholders is facilitated. These systems also drive stakeholder or user satisfaction and create a better work-life balance by increasing efficiency in trial management.
1. Centralized Data Management and Its Impact on Clinical Trial Efficiency
CTMS offers a multitude of features. One of the most important aspects is its role as a central repository for all study-related data. When set up correctly, it pulls information from various systems used in a study, such as EDC, interactive web response systems (IWRS), safety pharmacovigilance systems, risk management, and electronic trial master file (eTMF). All of this data is consolidated into a single central platform.
This capability enhances visibility, allowing real-time access to all information, which translates to improved quality. Faster decisions can be made because all data is readily available. Additionally, this system continues to drive down costs.
2. The Role of Process Automation in Clinical Trials with CTMS
At Innovaderm, 4 core values are upheld, one of which is seeking out innovation. Automating processes is a keyway to be innovative, as automation is neither straightforward nor a one-size-fits-all solution. For example, automation can be as simple as sending a notification or reminder to the team about an action item or study enrollment. Nowadays, these notifications or reminders are often referred to as “nudges,” which may seem less intimidating.
Automation can also be complex, such as managing the life cycles of action items or protocol deviations, which involve multiple steps and reviews by several individuals. Automation can handle all these steps efficiently. Ultimately, the goal of automation is to reduce or eliminate the manual workload of a process. This improvement ties back to enhancing trial quality, reducing costs, improving timelines, and increasing stakeholder satisfaction and work-life balance.
Efficiency Gains Through Process Automation
One of the areas at Innovaderm that continuously undergoes improvement is the monitoring reports process. Prior to transitioning to the current, more robust CTMS, letters and reports were primarily paper based with limited functionality for pulling data from different systems. CRAs had to spend considerable time cutting and pasting data from various systems, Excel sheets, or previous letters and reports. This process often led to issues with quality compliance.
The review cycle, being paper based, involved a tedious process of reviewing and placing comments. Additionally, there was a lack of visibility into cycle times and workflow, as nothing was tracked within a system. This resulted in low user satisfaction.
The current system enhances the flow of data into letters and reports, eliminating the need for cutting and pasting. Ensuring the accuracy of the data source improves the accuracy of letters and reports. The electronic system provides much greater visibility into the review process and cycle times. It allows for detailed metrics at study, country, site, and CRA levels. This improvement enhances quality, compliance, reduces costs, improves timelines, and ultimately provides a better experience for sponsors, sites, and employees.
3. Leveraging CTMS with Remote Monitoring Tools
The industry has been transitioning to a more risk-based monitoring approach for quite some time, moving towards increased remote monitoring. This shift is driven by trial cost consideration and the benefits of remote visits, which allow for more consistent and timely oversight compared to waiting for a CRA to visit a site, which could take anywhere from 4 to 8 weeks. During this time, data would be entered into the system, potentially leaving an 8-month gap in understanding site activities. Remote visits alleviate this issue.
A well-built CTMS system should facilitate remote monitoring activities. At Innovaderm, the transition to a more robust CTMS was designed to support these remote monitoring capabilities.
Advantages for Sponsors, CROs, and Sites
Again, it all ties back to the overall benefits of a CTMS system, such as lowering costs. Physical travel to a site to monitor data is no longer necessary. Overall operational costs are decreasing. The trial management team gains much more flexibility, allowing for the review of significantly more data remotely instead of requiring physical site visits. Data quality is enhanced due to the ability to review it continuously, compliance is improved, and there is a real-time assessment of the health or status of the study.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
Let’s shape the future of research and make a difference in the industry, gain Innovaderm’s support in your upcoming trial and propel your study to new heights
