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.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.