We are excited to share with you a newly published article co-authored by our Chief Scientific Officer, Dr. Johann Proeve, titled “Clinical Data Management in the United States: Where We Have Been and Where We Are Going.” This insightful publication explores the evolution of clinical data management (CDM) and its impact on biomedical research, diagnostics, drug development, and vaccine breakthroughs.
- The Shift in Clinical Data Management: The authors discuss how CDM has transformed from merely collecting and preparing clinical trial data for analysis to a multi-faceted endeavor that emphasizes quality data from study design inception to reporting and sharing of all applicable and available data.
- Influence of Legislation and Scientific Expertise: The article delves into the impact of FDA requirements, academic advancements, and technical innovations that have led to more precise and reliable CDM methods.
- Diverse Perspectives: The authors present the views of various stakeholders, including industry, academia, and non-profit organizations, highlighting the central role of CDM in coordinating expertise across these sectors.
- Dependence of Biomedical Research on CDM: The publication examines the importance of quality data in driving breakthroughs in diagnostics, drug development, and vaccines.
- Current Educational Programs and Future Needs: The authors discuss the state of existing CDM-related educational programs and suggest the creation of new interdisciplinary programs that can support the growing demands of clinical research.
- CDM as a Leader in Clinical Research: The article emphasizes the potential for CDM professionals to take on leadership roles in clinical research by overcoming obstacles in communication and staying up-to-date with technological advancements.
As clinical data management continues to evolve, it is essential for all stakeholders to stay informed about new developments and best practices. We are proud to have our Chief Scientific Officer, Johann Proeve, Ph.D., contribute to this groundbreaking publication that offers valuable insights and guidance for the future of CDM in the United States.