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
Aman Khera, MBA, FTOPRA, FRAPS
VP, Regulatory Science, Strategy, and Innovation
Aman Khera, Vice President, Regulatory Science, Strategy, and Innovation at Worldwide Clinical Trials, has been providing global strategic direction in regulatory affairs for nearly three decades. She has built her career on maintaining fastidious patient care with the pragmatism needed to help clients achieve effective regulatory and development strategies. Aman is available to consult with companies of all sizes, as well as their funding entities, to support their goals – with the primary aim of serving humanity as a whole.
