The Diversity Now Protocol by RxE2 provides a pharmacist-centered approach for compliance with Section V, Categories 4 and 5 of FDA's industry guidance (FDA Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials – Guidance for Industry, April 2022).
RxE2 has the AI-enabled technology platform to comply with all necessary enrollment requirements as set by the FDA.
In partnership with the local pharmacy, RxE2 uses its AI-enabled technology platform to search pharmacy demographics and data to identify strategic locations and potential participants to contact about clinical trials. Pharmacies are also already engaging patients and addressing other factors that can prevent participants from enrolling and staying with clinical trials.
RxE2 Releases Diversity Now, the First Protocol to Achieve Diversity in Clinical Trials According to the FDA Guidelines for Race and Ethnicity Diversity Plans. (2023, February 20). Cision PR Newswire.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.