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Tuesday, March 22, 2022 | 10:09 AM
Technology is intended to make our jobs and lives easier, however, complexity is inevitable. As clinical research and regulations evolve, the solutions we adopt to navigate this complexity are meant to bring order and efficiency. CTMS, perhaps above all other solutions, is specifically meant to deliver simplicity in oversight and process management. Yet, it can often involve a tangled web of configurations and reports that, technically, gets the job done, but not necessarily in a way that feels “right” for daily users like study managers and CRAs. Clinical research leadership (roles like CEO, VP of clinical operations, CTO, director of IT, etc.) look to these solutions to control costs, improve compliance, and minimize timelines, as well as improve the lives of their team members who are doing the day-to-day heavy lifting. If you’ve experienced these challenges first-hand, it’s not your imagination.
We refer to this miss in expectations as “The CTMS Gap.” Study managers and CRAs want to be able to see timelines, visualize critical data, and have confidence in their ability to stay compliant. They want the system to provide a guided, automated path for task completion. How do we close the gap?
The clinical industry has been notoriously slow to adopt new technology for operations, largely due to the change management impact. Homegrown setups, excel trackers, and the like are as familiar as they are inefficient. Implementation, configuration, validation, updates to best practices, work instructions, and SOPs are some of the essential milestones that need to be accomplished when adopting a CTMS. These milestones need not be obstacles in making the move to a more effective system. Identifying a partner who can execute these milestones on your behalf can take the weight off your shoulders and make change far more accessible. When taking on such a change, you should ensure that the CTMS system you choose provides the data visibility your team needs to be successful.
Many CTMS systems do not have effective ways for study managers and CRAs to see and use their data. By using activity plans, which are a business process flow and akin to work instructions, you can map out a series of steps required for a task to be considered complete. Being able to see the steps within a process, your progress, and how well you are tracking toward your goals helps both study team members and executives accurately assess the current situation and make proactive, predictive decisions. Activity plans can be mapped to milestones and can include critical dates, providing a clear, global view of progress. As a team member, you can see the parts of a plan or milestone for which you are responsible and easily differentiate the data that does and does not apply to your role. Completing activity plans equates to completing critical milestones. These plans ensure you are executing activities according to SOPs and ensuring your teams' compliance.
Capturing key metadata at the study, country, or site level allows for study managers to view and access key study-related progress details in as few clicks as possible, further streamlining the day-to-day.
For CROs, this approach simplifies viewing details to meet sponsor deadlines and maintain timely delivery dates. For example, an activity plan might specify 60 days with an actual due date of 65 days. If the CRO’s goal is to deliver early, they can leverage the view to track toward an earlier delivery date and account for tasks like QC, avoiding any delays.
In focus group sessions, it is evident study teams do not feel like existing solutions are designed from their perspective. At the end of the day, clinical professionals have to work in the system, and if they do not feel like the experience reflects their reality, it’s a miss! A user interface design that accounts for the various ways a study manager or CRA might need/want to get information is a huge win for those users. Often, they feel boxed into rigid designs that do not match their preferred approach. Some users like to use a navigation bar, whereas others like to move in and out of information using breadcrumbs (hyperlinks that allow you to trace your steps back to where you started). Each user is unique and rigid systems fuel user frustration. Users thrive on flexibility.
The experience of clinical professionals is important to align the CTMS to the business requirements of sponsors and CROs and to make it easy during implementation to defend what needs to happen, what is important, and why it is important to both clinical and technical team members. This alignment is an important but often overlooked aspect of change management. For example, why and when are we capturing the date for a subject? Knowing the business process helps with going another step further and asking whether you want to see a date after the site visit. Understanding the business process helps to make the experience better, more logical, and more comfortable for the user.
We touched on navigation earlier. CRAs and study managers do not want to feel like they are still in a spreadsheet, but, perhaps ironically, they do still want to have spreadsheet-like views at times. Card and grid views were common requests from our focus groups. Ultimately, flexibility is key and different users and people in various roles want to have unique views, as well as the ability to change the view based on preference. Visual summaries (think dashboards) help users rely less on large reports while giving them critical information to drill into if they need to look more closely. A user must be able to manipulate the data from the existing interface, rather than publishing and exporting reports. Filtering the data on the spot helps to gather more details regarding any area of concern, right there on the spot.
A big part of being practical is being flexible.
What elements in a CTMS should be configurable so study managers and CRAs can tailor the system to their business processes and needs?
Data that needs to be collected by the team to determine tasks within a given business process and any data and metadata that needs to be captured. Not every company completes a task and defines a business process in the same way. Your company’s process may require you to set a severity or capture an escalation. Being able to customize a CTMS to include those necessary statements is important. With the pandemic, teams needed to update their CTMS overnight to fit new data capture criteria. Having the ability to look at the study so you can identify your specific needs is important from a business perspective.
Systems that are not integration-friendly are the bane of IT teams’ existence everywhere. They are also the bane of executives and study teams who struggle to make use of data living in various systems. Robust, open APIs are necessary for systems like a CTMS that are helping you govern your entire study. Data needs to be able to move in and out with fluidity to get the most utility from the solution. Fluid means in real time, not an occasional data transfer or scheduled update. Having the ability to connect all the data from a central lab or central monitoring group with an open connector makes life easier. Reuse of data helps to ensure data quality. Having someone enter data multiple times in multiple systems increases the likelihood of it being different in different places, which equals risk. Your CTMS is like your study hub and should provide a single source of truth. If you enter a site list into the CTMS it should automatically send the site and contact details needed to the IxRS, drug supply, etc. You should only have to perform a task once in the system. Essential interoperability with eFeasibility, Study Start-Up, eTMF, QMS, DMS, eISF, etc., allow for a consolidated view of activity across the study.
Study teams do not want their workstreams confined to the lab. Clinical research is not immune to the revolution in remote work, and the workforce is becoming increasingly populated with digital natives. Mobile interfaces also ensure workflows are not confined to a desk, affording more flexibility with where, when, and how tasks can be completed. Simply put, a mobile experience is a must-have convenience for the modern workforce. Completing monitoring visits and trip reports is one of the more pragmatic use-cases for mobility, and one our users appreciate having at their fingertips.
CRAs and study teams need an increased level of accountability to mitigate risks. Now, there is no shortage of accountability in clinical research. Accountability is certainly not novel. That said, having the right measuring sticks for accountability can improve how actionable accountability is or isn’t. For example: Are the CRAs meeting the defined business process for a trip report? The ability to compare CRA performance indicates where there is a need for training, process improvement, etc. Looking at activity across a study highlights areas of concern as well as areas where performance shines. It allows you to optimize. KPIs provide quick views into critical processes that allow you to make decisions as the study progresses and perform risk-based analysis. When the system automatically highlights trends and problem areas, perhaps color-coding the data and sending alerts, it is much harder to overlook important triggers for action.
Simply put, if we have the data in the system, we can create automation around it. For example, a study manager may know a certain event means the study will be closed, like a country reaching a status of closeout. With this knowledge, that process can be automated. Activity plans may only be relevant at certain times. Using the data parameters, a study manager or CRA’s view can be simplified by only showing them the plans that are relevant at the time. When site visit reports are in, the eTMF can be automatically notified that the visit is complete. Likewise, the system can alert you when a report is due on a visit to make sure records are complete and filed appropriately (and automatically).
Studies are becoming increasingly global. There is a greater emphasis on diversity and inclusion, as well as an emphasis on decentralization. These and other realities necessitate that your CTMS interface is translated into as many languages as possible. A multilingual interface will remove any language barriers from your operations.
There is always room for growth. We are tackling a lot of the big challenges, but with that innovation comes an opportunity to do more: more integrations, more elegant interfaces, more focus on mobile, more automation with AI and machine learning. In the short term, study teams need us to close the CTMS gap and deliver an experience that meets their real-world needs. They need practical innovation as much as they need powerful innovation.
For more information on Trial Intetractive’s CTMS, contact us at firstname.lastname@example.org.