Health Equity and Inclusivity in Clinical Research
At Worldwide Clinical Trials, we are committed to advancing science by ensuring that clinical research reflects a diverse range of patient populations, demographics, and co-morbidities. We believe that this representation is crucial for developing treatments that are effective and accessible to everyone
We offer comprehensive solutions across clinical program development, regulatory strategy, diversity action planning, and operational solutions in trial delivery.
Representative Clinical Trials, Worldwide
Global regulatory agencies are emphasizing the importance of how different populations respond to treatment. Health authorities in various regions now expect drug developers to have formal Diversity Action Plans in place during the clinical development process – typically requiring these to be available by phase III but to consider starting earlier to benefit from aggregated data across a development program. Implementing a formal Diversity Action Plan brings several strategic advantages to your drug development program, such as:
- Informing protocol design and trial delivery
- Priming new drugs for commercial success by ensuring comprehensive efficacy data
- Mitigating long-term costs to drug development associated with post-market surveillance requirements
Global Regulatory Expertise & Inclusive Clinical Research
Worldwide offers practical knowledge in global regulatory environments through all phases of the drug development process. Additionally, we provide extensive industry experience shaping project plans to ensure clinical data is representative of patient populations, further enforcing scientific validity and generalizability. Our approach includes:
- Strategic Planning: Consulting on inclusive trial design early on
- Regulatory Compliance: Adhere to local regulatory standards across all global regions
- Representative Data: Setting realistic targets for diverse patient populations to ensure representative data
- Site Selection: Choosing and supporting sites for representative enrollment
- Operationalization: Effectively implementing and measuring inclusive strategies
Operationalizing Health Equity Strategy
At Worldwide, we implement a personalized operational approach with experts from all functional areas of project delivery.
Our Solutions:
- Identify and mitigate barriers to participation
- Engage and deploy vendors and other solutions to support site-level operations and patient recruitment
- Incorporate the patient’s voice into the discovery and development process
