June 2025, Volume 3, Issue 6

Author

Thrupthi D L, Harshwardhan Patil, Rajath K Bharadwaj, Sameeksha K and Srikanth MS

Abstract

Background: Clinical trials are conducted with a set of ethical standards, patient safety measures, and scientific scrutiny. Clinical Data Management Systems have evolved over time, shaped by historical milestones, technological advancement, and international harmonization. Objective: This paper aims to analyze real-world evidence and data protection approaches provided by Health Canada, Food and Drug Administration and the European Medicines Agency, and their impact on regulating clinical data. It also discusses modernization of regulatory frameworks. Methods: This study is based on empirical legislative documents from international regulatory bodies. Literature from PubMed Central, ScienceDirect, and Google Scholar was consulted to analyze Good Clinical Practice, data integrity, and global data synchronization. Results: All agencies reviewed have robust frameworks ensuring data quality, safety, and transparency. Developments include GCP guidelines, electronic data standards (e.g., FDA 21 CFR Part 11), public release policies (e.g., PRCI), and harmonization via ICH guidelines. Real-world evidence (RWE) has expanded post-marketing surveillance and regulatory paradigms. Conclusion: Despite regional differences, convergence around international standards and digital systems has strengthened global clinical trial ecosystems. Continuous evolution is needed to adapt to new data sources and safeguard patient welfare.