Clinical Study Meta-data Monitoring

Background:

Cook Research Incorporated (CRI, West Lafayette, IN) is a research company that is part of Cook Medical. One of the main activities of CRI is to design and implement clinical data collections (clinical trials) to support medical devices manufactured at Cook Medical companies. Clinical trials provide a rich source of data, not only on the medical devices and patients, but also on the operational aspects of the trial such as timeliness of data entry, mistakes in data entry and clarity of the provided data.

Project Description:

Following the successful implementation of a PowerBI dashboard to monitor key operational aspects of clinical trials—including site status, patient enrollment rates, early exit rates, and query metrics—this project will focus on enhancing analytical depth, usability, and automation of the existing system.

The next phase aims to:

• Refine existing metrics and visualizations based on stakeholder feedback.
• Integrate new operational meta-data types.
• Incorporate forecasting/prediction capabilities for key metrics.
• Introduce automated alerts and threshold-triggered flags to proactively direct resource allocation.
• Explore methods for benchmarking hospital/site performance across trials.
• Improve interactivity and user experience in the dashboard, enabling drill-downs and custom filtering.

Tasks will include:

• Expanding and refining metric definitions
• Collaborating with stakeholders to determine new actionable thresholds
• Engineering new data views and statistical summaries
• Enhancing the existing PowerBI tool with layered navigation and data interaction
• Exploring predictive modeling approaches for operational risk indicators

Students who are majoring in statistics, data science, and computer science, and are interested in applying their skills in programming more advanced calculations and metrics, as well as trying to ensure that complex data is presented to provide business decision-making are encouraged to register.

Keywords:

Data analytics, data analysis, data visualization, statistics, statistical modeling, predictive analytics, predictive modeling, clinical trials, operational metrics, forecasting, benchmarking, interactive dashboards