Expertise: Clinical Development 61 results

Clinical Development

Advancing Health Outcomes for All: Addressing Diversity and Ethnicity Data Challenges in Global Clinical Research

In the business of pharmaceutical and MedTech clinical development, the significance of robust data cannot be overstated. It serves as the cornerstone for informed decision-making and cultivates an environment where innovation thrives. However, when confronted with the task of comparing ethnicity data across diverse countries, a myriad of challenges and intricacies surface, warranting a thorough…

Clinical Development

The Ascendance of Site Managers to Meet the Dynamic Needs of Clinical Research

The increasing complexity of clinical trials requires a re-assessment of the functions of site management and monitoring. Both roles have traditionally been the purview of clinical research associates (CRAs), who have typically spent 60%-80% of their time on monitoring and only 20%-40% on site management. Traditionally, CRAs have a range of monitoring and site management…

Clinical Development

4 Steps to Implementing DEI in Clinical Trial Design and Patient Recruitment

Welcome to part two of our blog series focused on the integration of diversity, equity, and inclusion (DEI) into clinical research. If you missed part one of the series that highlights recent FDA initiatives and legislative changes behind these developments, click here. In today’s clinical research environment, sponsors face the challenge of comprehensively incorporating DEI…

Clinical Development

FDA’s Push for DEI in Clinical Trials: What Sponsors Need to Know in 2024

In the ever-evolving field of global clinical research, the integration of diversity, equity, and inclusion (DEI) has become a pivotal focus, especially considering recent FDA initiatives and legislative changes. The U.S. Food and Drug Administration’s (FDA) ongoing efforts, coupled with the enforcement of the DEPICT Act and impending final regulatory guidance, highlight the urgency and…