Dassault Systèmes’ subsidiary Medidata has announced the launch of the new Intelligent Trials Diversity Module which will help sponsors and clinical research organisations (CROs) improve study diversity and inclusion.
The module will provide site-level participant demographic data including sex, race, age, and ethnicity to help enhance the equity of trials.
Leveraging the new Intelligent Trials Diversity Module, sponsors and CROs will be able to benchmark the diversity of their trials and also find successful sites for enrolling patients.
Medidata AI senior vice-president Fareed Melhem said: “Powering greater diversity is critical for our industry and a priority for Medidata.
“With this new offering, it is now possible to identify high-performing sites known to recruit diverse patients.
“By providing our standardised and analysis-ready demographic and operational data in a study’s planning stages, sponsors and CROs can optimise planning and diversity performance from the start.”
The Intelligent Trials module will offer a competitive edge in the planning and execution of clinical trials by bringing together predictive models, cross-industry real-time performance metrics, and forecasting capabilities.
Its addition, it will also enable sponsors and CROs to set goals by benchmarking diversity at the study level in the same indication.
The Intelligent Trials offering from Medidata further supports the draft guidance issued by the US Food and Drug Administration (FDA) to the industry.
This guidance was released to develop plans for enrolling more participants from underrepresented racial and ethnic populations in the country into clinical trials.
In June this year, Medidata introduced new clinical operations technologies for addressing key issues related to the management and oversight of clinical trials.