Diversity and Inclusion Study Insights Dashboard

The Diversity and Inclusion Study Insights Dashboard is designed to support diversity action plans in clinical trials. It helps meet regulatory requirements by ensuring therapies are developed in populations that reflect real-world demographic characteristics.

With proven experience, the team has completed approximately 15% of the drug products and medical device plans submitted to the FDA. This expertise aids in advancing negotiations with regulators for concurrence on Diversity Action Plans.

The dashboard leverages powerful technology to provide in-study diversity insights. It offers real-time monitoring of participant demographics, including race, age, sex, and ethnicity, from study startup through conduct and closeout. This enables the identification of population-specific signals and the assessment of the safety and effectiveness of study drugs.

Key Features:

• Analyze data by demographic characteristics to identify population-specific signals.
• Assess safety and effectiveness based on key parameter profiles of enrolled subjects.
• Review subject withdrawals and lost to follow-up cases to refine retention strategies.

With these insights, users can make informed decisions to assess the impact of their Diversity Action Plan, adjust enrollment and retention strategies, implement corrective actions, and generate reports to support ongoing regulatory engagement.

The dashboard is part of a broader effort to create solutions beyond the plan, supporting the implementation of Diversity Action Plans that set diversity goals and eliminate participation gaps. It integrates consulting services, mobile and digital capabilities, and a strong investigator site network to enhance patient access and improve healthcare outcomes.

Overall, the Diversity and Inclusion Study Insights Dashboard provides a comprehensive approach to diversity planning, utilizing real-world data and expert consultation to set realistic diversity goals and map out a path forward.