Clinical trials are crucial to modern healthcare industries, and information technologies have been employed to improve the quality of data collected in trials and reduce the overall cost of data processing. While developing software for clinical trials, one needs to take into account the similar patterns shared by all clinical trial software. Such patterns exist because of the unique properties of clinical trials and the rigorous regulations imposed by the government for the reasons of subject safety. Among the existing software development methodologies, none, unfortunately, was built specifically upon these properties and patterns and therefore works sufficiently well. In this paper, the process of clinical trials is reviewed, and the unique properties of clinical trial system development are explained thoroughly. Based on the properties, a new software development methodology is then proposed specifically for developing electronic clinical trial systems. A case study shows that, by adopting the proposed methodology, high-quality software products can be delivered on schedule within budget. With such high-quality software, data collection, management, and analysis can be more efficient, accurate, and inexpensive, which in turn will improve the overall quality of clinical trials. 1. Introduction Clinical trials (CTs) are measures to evaluate the safety and efficacy of a medical device or drug. CTs are crucial to modern healthcare industry and usually take substantial resources and time to complete with four major parties involved: the sponsor, the government agency, the participating hospitals (or sites), and the patients (or subjects) [1]. The clinical trial is usually supported financially by a sponsor that may be a pharmaceutical company, a medical device company, or even a government agency. Sponsors also define the scopes, procedures, protocols, and goal of their CTs. The definition of “protocol” in clinical trials is very different from the one commonly used in the computer engineering (please refer to the US Food and Drug Administration (FDA) for more information [2]). Data are collected on sites from subjects and recorded on well-defined forms, that is, case report forms (CRFs), to guarantee the quality of the collected data. For the safety of subjects, CTs should always follow predefined protocols and government regulations. Today, almost all fields, including the healthcare industry, are benefited by high-speed computers and information technologies [3, 4]. High-speed internet accessibility is one of the prime examples. For computerizing
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