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Gartner defines e-clinical systems as software solutions or platforms that facilitate clinical trials by supporting study setup, conduct, and analysis. The clinical trial process begins with a protocol outlining trial methodology and ends with results and conclusions in a clinical study report. E-clinical systems streamline this process by collecting, cleaning, and interpreting trial data, and supporting site monitoring, biostatistics, and clinical supply management. These systems enable life science organizations to optimize and scale clinical trials globally, transforming them from labor-intensive, paper-based processes to efficient digital ones. E-clinical systems accommodate trials ranging from Phase 1 at a single site with hundreds of volunteers to Phase 3 with hundreds of sites and thousands of participants. While stand-alone solutions exist, e-clinical systems are typically deployed as global, multitenant platforms that integrate solutions across clinical trial operations. They manage and support trials by integrating multiple solutions, beginning with building the study application in an electronic data capture (EDC) environment. This setup allows for clinical management, supply management, and data entry. As trials progress, sites are added, and data is entered by site personnel during participant visits. The data is then reviewed, cleaned, and the database locked to prevent further changes. E-clinical systems support both content and data flow, characterized by solutions for key business areas involved in trial execution. These include EDC for data management, a clinical trial management system (CTMS) for trial operations, and a statistical compute environment (SCE) for biostatistics. Despite advancements, the process remains partly digital, with significant potential for improvement by converting paper-based processes into digital and mobile-based solutions, ultimately leading to fully digital trials.

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