PAID MESSAGE – There’s no denying that Clinical Research Associates (CRAs) work with a lot of data. In their daily work of monitoring and reviewing clinical studies, they must evaluate information from multiple sources to verify its integrity and observe potential risks to the trial or timeline. The right technology makes a measurable difference in how CRAs handle their workload and support a trial.
Addressing common pain points
Consider the challenges that CRAs face in their work. Many studies have complex protocols, and amendments are common once a study is under way. It can be challenging to ensure sites keep up with these study-specific nuances and consistently verify high-quality data. Further, given that CRAs only monitor a subset of the sites working on a protocol, it is impossible for a CRA to identify trends across sites without a technology designed for this purpose.
To easily identify specific areas of concern and better pinpoint risks at study sites and across a program, Covance developed an integrated suite of clinical trial management solutions, called Xcellerate®, to help:
Identify site-level risks before the trial begins: Every CRA knows that no two sites are the same. An automated platform can evaluate the feasibility and historical performance data to determine the baseline risk level for each unique site. With this risk profile, a CRA can develop a site-specific strategy for monitoring.
Proactively alert to required actions: Instead of waiting until the next monitoring visit or central monitoring assessment, the study team receives daily, automated reviews of incoming data that also provides an alert when important metrics have crossed a defined threshold.
Focus on appropriate mitigation actions: Through proprietary algorithms and analytics, central monitors and CRAs can quickly identify sites with increased risk, determine the highest and lowest risk factors across a whole study and filter by countries with the highest risk sites. The central risk-based monitoring (RBM) review team can drill down to individual sites, prioritize risks and develop appropriate mitigation actions to ensure compliance to the monitoring plan.
Find risks by identifying outliers: Working with study data in a centralized database, monitors can also create plots to compare variables, such as adverse events vs. patient exposure, as a means to quickly identify potential underreporting.
Automate documentation of issues and actions: All actions and issues from any source, including central monitoring, are submitted to a holistic issue management platform that escalates automatically, sends notifications of actions that are newly assigned or approaching due date, and allows for documentation of study team review.
Elevating team synergy with clinical informatics technology
Tracking issues in a unified risk management system allows for multiple parties to be connected to the same real-time information. Viewing data from risk assessments, central monitoring and site monitoring provides staff with a holistic view of all issues, actions, protocol deviations, decisions and risks. When an issue such as a protocol deviation is recorded, the event can be automatically escalated to the appropriate parties, ensuring that the information isn’t lost in an unread email and eliminating the need for manual tracking. These advanced analytics also highlight high-risk areas so the review team can help drive accountability and focus on the issues that matter most to a study’s success.
Enhancing CRA-specific tasks
CRAs often rely on a number of different technologies, platforms and spreadsheets to track issues and progress at each site. Covance recognized the day-to-day complexity of the site management process and created a CRA Dashboard to consolidate multiple data streams into a single view. With just a few taps on a mobile device, CRAs can view key dates, compliance data, patient enrollment, trip reports, protocol deviations and pages requiring source data verification (SDV), among other metrics.
Reviewing study-specific operational and performance data helps CRAs focus their attention on problem areas, supports great site compliance and helps enable more meaningful data-driven discussions with sites.
Just as the efficiency of a trial is evaluated, the tools to support the trial must also be tracked and measured. Initial data from the Covance CRA Dashboard showed an average reduction in site management time of 18% and a 22% reduction in preparation time needed for routine monitoring visits. In addition, the average number of days were reduced for open issues while the teams observed increased compliance for the monitoring strategy.
Enabling transparency with monitoring technology
Running an efficient, well-managed clinical trial requires the right information at the right time. Clinical informatics technologies must continue to improve and evolve with today’s complex drug development landscape. Not only can these technologies help ensure that CRAs and central monitoring teams can serve as highly-effective site managers, but sponsors can become more involved in the process and gain awareness of real-time progress. Providing this level of visibility builds a culture of transparency, creates a stronger relationship between a CRO and a sponsor and ultimately helps optimize clinical trial performance.