Diversität und Inklusion in klinischen Studien

Supporting Diversity Action Plans

Work with a partner that’s invested in your diversity goals.

Diversity in clinical trials is a legal requirement in the U.S. and critical to ensure that therapies are developed in a population that reflects the ethnic and racial diversity of the real world.

At Fortrea, we are committed to writing and supporting the implementation of Diversity Action Plans that will set diversity goals and help eliminate gaps in participation. Throughout your clinical development, we act as an extension of your team to support your diversity goals and inclusion practices in clinical trials. With our unique combination of consulting services, mobile and digital capabilities and our innovative Diversity and Inclusion Insights Dashboard, we're ready to enable greater patient access and improve healthcare for all.

Lassen Sie uns ein Gespräch beginnen

Create and write a robust Diversity Action Plan with our experienced team to ensure your program includes diversity demographic targets that reflect the population to which your product will be prescribed in the real world.

Support negotiation with regulators for concurrence on your Diversity Action Plan.

Enable in-study monitoring to observe trends and dynamically adjust your enrollment strategies with our proprietary platform.

Enable an integrated approach to achieve your diversity goals in your program.

To comply with regulations and meet requirements for diverse representation in clinical trials, we offer an integrated approach that encompasses Diversity Action Plan writing, regulatory negotiations, implementation and in-study diversity monitoring through our proprietary platform to track your program's progress.

Let’s reflect diversity throughout your clinical development.

To help you achieve your diversity goals, we offer an integrated five-part process:

Researching real-world data to inform diversity planning.

Diversity planning begins with a thorough epidemiology assessment to determine the prevalence of the disease in the target patient population utilizing real-world data (RWD) and literature. As part of informing your Diversity Action Plan, our experts provide consultation to understand the requirements, applicability to your program and map out a path forward. Starting with this research, we work with you to understand the data and set realistic diversity goals.

Providing dynamic preparation of your Diversity Action Plan.

Your Diversity Action Plan is a multi-functional document. We serve as an extension of your team and work with subject matter experts from across our organization to prepare and write your Diversity Action Plan. After your plan is submitted, we negotiate with regulators on your behalf.

Implementing your Diversity Action Plan.

With access to multiple data platforms, our Site Advisory Board and technology-enabled solutions, our team at Fortrea identifies where the target diverse patients are located and implements strategies to attract and retain them.

Monitoring enrollment diversity and end-of-study reporting.

Track progress toward your study diversity goals with our proprietary platform: The Fortrea Diversity and Inclusion Study Insights Dashboard. Our library of visualizations can track relevant demographics, focus on specific screen failure rates and assess the safety and effectiveness of the study drug, based on key parameter profiles of the subjects enrolled.

Supporting regulatory interactions.

Your Diversity Action Plan is a living document. Throughout a study and a program, we continue to gather metrics, write reports and support your discussions with regulators, as needed.

Leverage powerful, in-study diversity insights.

The Fortrea Diversity and Inclusion Study Insights Dashboard

To help ensure your study is reflective of a real-world population, we can provide in-study monitoring of the predefined demographic and non-demographic characteristics to monitor the enrollment of participants.

From study start-up through conduct and close-out, our proprietary dashboard can:

Analyze data by race, age, sex and ethnicity to assist with the identification of population-specific signals
Enable the assessment of the safety and effectiveness of the study drug based on key parameter profiles of the subjects enrolled
Review any subject withdrawals and those lost to follow-up cases across different cohorts/sites to refine your retention strategy

With powerful, in-study diversity data from the Fortrea Diversity and Inclusion Study Insights Dashboard, you’ll have an on-hand view of current trends in your trial so you can:

Make informed decisions to assess the impact of your Diversity Action Plan
Adjust your enrollment and retention strategies
Implement corrective actions
Generate reports to support ongoing regulatory engagement and filing

Throughout your clinical development, we act as an extension of your team to support your diversity and inclusion practices.

Together, let’s advance our shared goals to deliver more meaningful clinical research.

Unterhalten wir uns

Ihre Anforderungen. Unsere Lösungen.

Als Anbieter eines umfassenden Managements klinischer Studien der Phasen I bis IV, klinischer Pharmakologie, von Lösungen für den Patientenzugang und anderer grundlegender Dienstleistungen arbeitet Fortrea mit aufstrebenden und großen Biopharma-, Medizintechnik- und Diagnostikunternehmen zur Förderung von Innovationen im Gesundheitswesen weltweit zusammen.