COMPUTERIZED CLINICAL TRIAL DATA ACQUISITION & ANALYSIS

新的药物和医疗程序必须经过临床试验 才能通过食品和药物管理局的认证收集和处理 试验数据，以及临床的一般管理 过程，可能既耗时又容易出错。我们的目标是 减少研究人员的时间和行政负担， 他们进行额外的研究，通过为他们提供一个计算机化的 持续跟踪和报告这些数据的方法。 在本SBIR中，剑桥计算机联合公司，及其研究 附属公司，BioSurface Technology，Inc.建议开发一个基于PC的， 用户友好的软件系统，允许个人研究人员 自定义CRF自动收集数据（通过电信）， 试验中心，并进行有效性检查，统计分析， 报告. 现有的系统价格昂贵，经常偏离不断发展的行业 标准，并提供不完整的解决方案。 第一阶段的工作将确定最终的 系统，确定要集成的适当的现有软件包， 组件，指定新的软件，并准备一个初始原型。

New medications and medical procedures must undergo clinical trials before they can be certified by the FDA. The gathering and processing of trial data, as well as the general administration of the clinical process, can be both time-consuming and error-prone. Our goal is to reduce the time and administrative burden placed on researchers, freeing them for additional research, by providing them with a computerized method of tracking and reporting these data consistently. In this SBIR, Cambridge Computer Associates, Inc., and its research affiliate, BioSurface Technology, Inc. propose to develop a PC-based, user-friendly software system that allows individual researchers to customize CRF's collect data automatically (via telecommunications) from trials sites, and perform validity checking, statistical analysis, and reporting. Existing systems are expensive, often deviate from evolving industry standards, and provide incomplete solutions. The Phase I effort will define features and functions of the final system, identify appropriate existing software packages to integrate as components, specify new software, and prepare an initial prototype.