Clinical research associates (CRAs) need immediate access to relevant and accurate site performance metrics, but information is often isolated within multiple databases and spread across different tracking systems. To deliver key site performance data to CRAs via mobile and web applications – quickly and conveniently – we have created a specialized clinical analytics suite of products, Xcellerate® Informatics. This powerful solution integrates data from all sources and allows a CRA to gain a clear and concise view of all clinical trial data, in one place, for all the sites that a CRA is monitoring.
Strategic responses to an evolving environment
As a single product that provides site-level visibility for CRAs, the Xcellerate® CRA Dashboard was developed to support clinical monitoring strategies based on the principles of risk-based monitoring (RBM) and ICH GCP E6 (R2).
This industry-leading product gives CRAs the essential information and insights for proactive strategic planning and provides CRAs with a vital link between investigative research sites and functional teams by facilitating collaboration and streamlining communication efforts with their site partners.
As the only CRO to offer a mobile application for its CRAs, we are changing the game. This product, designed to focus a CRA’s attention on areas of risk, seamlessly integrates study-specific operational and project performance data. As CRAs work to drive improvements in site compliance through riskdirected actions and meaningful data-driven discussions, this product aids in visual site performance. Additionally, the Xcellerate CRA Dashboard provides essential information such as trip report compliance data, patient enrollment data, query and issue aging metrics and protocol deviation details.
Tracking performance metrics
Since the product launch in November 2017, we have closely monitored the adoption of the Xcellerate CRA Dashboard, incorporating user feedback and tracking performance metrics. The initial feedback and metrics are strong. Nearly two-thirds of our CRAs have utilized the product and efficiency analysis demonstrates an average of 18% reduction in site management since launch. Similar reductions have been observed in routine monitoring visit (RMV) preparation time, with a 22% reduction since launch.
Further analysis of operational data also shows improvements in Issue and Risk Aging and strategy compliance since the Xcellerate CRA Dashboard launch. As internal teams further embrace the Xcellerate CRA Dashboard, we will continue to collect and analyze performance metrics to quantify differences in time, efficiency and quality as related to the CRA’s role and responsibilities.
Increasing overall CRA satisfaction
Beyond the promising metrics from the initial rollout, CRAs no longer have to hunt through multiple data streams to access pertinent information. This saves a tremendous amount of time for CRAs, and provides them with swift access to key information, further empowering their role as a partner to study sites. As one CRA states, “I am amazed to see the power of data, and how it makes sense when it all comes together in the Xcellerate CRA Dashboard.”
The ability to gain clinical trial insights on a mobile device also makes a difference for CRAs who are often on the move. “I can access the Xcellerate CRA Dashboard anywhere anytime,” said a CRA. “I found an easy-to-use and very effective way to increase my awareness of the site overview.”
With immediate access to key site performance data through the Xcellerate CRA Dashboard, the role of the CRA is evolving to optimize the use of specialized skills as part of a cross-functional risk management team. The future is bright for these adaptable CRAs looking to strengthen their clinical monitoring skills and use innovative clinical informatics technologies.