Sarcouncil Journal of Multidisciplinary

Abstract: The low-code platform implementation in the form of digital transformation of clinical trial management is a paradigmatic change in the field of healthcare research operations that allows addressing the long-existing issues related to the traditional paper-based approach and the use of fragmented information systems. The modern clinical research setting is highly inefficient in terms of operations due to a manual data gathering process, complicated regulatory compliance rules, and difficulties in coordinating numerous stakeholders such as research sites, regulatory organizations, and patient groups. Low-code platforms have been introduced as revolutionary tools that can help healthcare organizations quickly implement tailor-made clinical trial management applications that do not need considerable levels of programming to support operational efficiency and regulatory compliance. The implementation will involve end-to-end electronic processes such as electronic data capture systems, automatic quality control systems, and built-in audit trail functions, which cover the regulatory frameworks of electronic records and data integrity requirements. Operational performance assessment shows significant positive changes in the schedule of operations, data quality indicators, and stakeholder satisfaction rates. In contrast, the economic analysis indicates positive cost-benefit ratio results with regard to decreased administrative overhead and increased resource use. In its technology adoption, there are advanced compliance mechanisms that cover the aspects of electronic signature, validation rules, and risk management models to ensure regulatory acceptability in the course of conducting operations during clinical trials.