Health Equity, Diversity, and Inclusion in clinical research
You need a CRO who ensures diversity, equity, and inclusion (DEI) is at the forefront of study delivery and outcomes. At Worldwide Clinical Trials, we offer comprehensive solutions across clinical program development, regulatory strategy, diversity action planning, and operational solutions in trial delivery.
The Health Equity Task Force is comprised of experts at all functional levels who develop the framework of our Diversity Action Plans, ensuring operational implementation across all the study’s teams.
Accessible Health Equity Knowledge
The Food and Drug Omnibus Reform Act (FDORA) was signed into law December 2022, taking effect January 1, 2023. This recent legislation mandates that all drug developers create and submit a formal Diversity Action Plan no later than the end of Phase 2. An operational Diversity Action Plan brings numerous benefits to your drug development program, including:
- Mitigating long-term costs to drug development associated with post-market surveillance requirements
- Priming new drugs for commercial success by ensuring comprehensive efficacy data
- Informing protocol design and trial delivery
Global & Regional Regulatory Expertise
Worldwide offers practical knowledge in the North American and International regulatory arenas through all phases of the drug development process. Additionally, we provide extensive industry experience shaping project plans to meet Diversity Action Plan requirements.
Our Solutions:
- Consultation and development of Diversity Action Plans
- Oversight of pre-award and post-award operations
- Ongoing monitoring of DEI performance
Operationalizing Health Equity Strategy
At Worldwide, we implement a customized operational approach with experts from all functional areas of project delivery.
Our Solutions:
- Review and confirm that protocol is not overly limiting
- Identify and mitigate barriers to participation
- Engage and deploy vendors and other solutions to support site-level operations and patient recruitment
Meet Our Health Equity Leadership
Daniel A. Perez, CCRP
Director, Health Equity Strategy
- 14+ years of clinical research experience
- Serves Worldwide’s patient engagement, diversity, and inclusion efforts across 60 countries and five therapeutic areas
Aman Khera, MBA, FTOPRA, FRAPS
VP, Regulatory Science, Strategy and Innovation
- Nearly 3 decades of success within the CRO environment in providing regulatory and strategic advisory expertise.
- Works as an accomplished leader with a strong passion in Regulatory Science and Health Equity
