USE OF ELECTRONIC DATA CAPTURE SYSTEMS IN CLINICAL TRIAL MANAGEMENT

The article examines is to investigate the use of Electronic Data Capture (EDC) systems in the management of clinical trials, as well as to analyze their impact on the efficiency, accuracy, and transparency of clinical research processes. Special attention is given to the study of the functional capabilities of modern EDC systems, their integration with other digital tools, compliance with international standards and the challenges of implementation in Ukraine. To achieve this goal, methods of analysis and systematization of scientific publications, regulatory documents, and comparative assessment of different EDC platforms were applied. Practical examples of EDC usage in pharmaceutical companies, contract research organizations (CROs), and academic institutions were studied, and their advantages, limitations, and development prospects were evaluated. Key functions of EDC systems were identified: centralized data collection and storage, automated validation and quality control, audit and reporting, integration with laboratory and electronic health record systems. The analysis demonstrated that EDC use contributes to reducing data entry errors, shortening monitoring time, improving research transparency, and ensuring regulatory compliance. Implementation challenges were also discussed, including high licensing costs, staff training requirements, cybersecurity, and integration with local healthcare systems. The article also examines the future development of EDC: the use of artificial intelligence for anomaly detection, automated protocol deviation control, blockchain technology for data integrity, cloud solutions for multinational trials, and integration with wearable devices and telemedicine. The development and implementation of EDC in Ukraine require strengthened regulatory support, coordination among clinical sites, government bodies, and industry, as well as active training of specialists for working with digital research tools.