Clinical Data Systems for Global Trials: Advancing Regulatory Success and Improving Outcomes for Patients Worldwide toward Better Treatments for Society

Abstract

The success of global clinical trials is ultimately reliant upon robust Clinical Data Systems and infrastructure for data integrity, regulatory compliance, and rapid patient access to new treatments. To efficiently manage clinical data  advanced data management systems are required to integrate complex, multinational data sets, while providing the highest levels of quality and regulatory acceptability.  The Clinical Data Systems have the main technology that allows pharmaceutical companies to present the SDTM/ CDISC compliant clinical study data to regulatory authorities to review and render judgments about new medical products with confidence, allowing for timely approvals and drug development, and enhancing patient access to therapies around the world. Clinical Data Systems are a suite of emerging technologies that have Electronic Data Capture (EDC) platforms, automated validation products, and risk-based monitoring capabilities that are beginning to redefine the clinical trial paradigm. Both worldwide standardization, such as Clinical Data Interchange Standards Consortium (CDISC), provide a degree of assurance in the representation of data in decision-making from different regulatory jurisdictions, while allowing patient-reported outcomes and real-world evidence to be integrated easily. This type of technological capability also results in clinical trial designs that can be more representative of the global population and improve the generalizability of clinical results across diverse populations in various locations.The compliance features of contemporary Clinical Data Systems, which deal with intricate requirements such as electronic management of records, extensive audit trail management, and multi-faceted security measures to protect patient confidentiality while guaranteeing data validity, have helped bring about worldwide regulatory harmonization efforts, greatly increased submission acceptance rates, and shortened review timescales to the ultimate benefit of patients through quicker access to life-preserving medications. The social impact reaches beyond individual patient results to include drug development economic efficiencies, increased public confidence in clinical trials, and more efficient delivery of healthcare in developed and emerging countries.