Development of Distributed Electronic Clinical Trials

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Description (provided by applicant): Today over 80 percent of clinical trials are still conducted utilizing paper forms for data collection. Transcription of data from paper source documents to a central database is expensive and an additional source of error in clinical trials. With the advent of the Internet and low-cost personal computers, custom software has been developed for clinical trials, dramatically increasing data accuracy and reducing the average time it takes to complete a clinical trial. The major problem with these applications is the large expense to develop custom software. This expense combined with the fact that many clinical sites are running various operating systems and practice management software prove to be major drawbacks to current clinical trial software. In this proposal, INFOTECH Soft will develop an integrated clinical trial development and distributed administration framework to reduce the cost and increase the efficiency of creating and administering clinical trials. The major technical issues addressed by the proposed system are the portability of the administration environment through the use of the Internet and handheld mobile devices, the portability of clinical forms and clinical data through the use of open XML standards, the ability of clinical investigators to quickly create and manage electronic clinical trials, and the ability of the system to be integrated with existing information systems. As a result, the system is inherently better and more sophisticated compared to current paper-based and computerized techniques. The INFOTECH Soft solution includes four major components, the Clinical Trial Developer, Clinical Trial Administrator, Clinical Trial Database, and Systems Integration. The system utilizes the Internet and handheld mobile devices to provide easy coordination of clinical trial data. PROPOSED COMMERCIAL APPLICATION: The system enables the creation of customized flexible electronic clinical forms, which is especially important in clinical trials where new and experimental procedures, requiring custom-built clinical forms, are evaluated. Support for Internet and mobile handheld devices. Incorporation of a clinical study database for storage and retrieval of subject data along with the utilization of open data interchange protocols are essential features for sharing and exchanging information in clinical trials.