CTASC-Clinical Trials Management System

CTASC-临床试验管理系统

基本信息

批准号：
7763569
负责人：
Margaret M Frederick
金额：
$ 75万
依托单位：
CLINICAL TRIALS AND SURVEYS CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-09-15 至 2010-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7763569
关键词：
Accounting Advertising Architecture Archives Area Automation Award Budgets Businesses Case Management Client Clinical Research Clinical Trials Code Computer software Conduct Clinical Trials Data Databases Defect Development Documentation Elements Ensure Environment Failure Guidelines Internet Java Job Description Journals Knowledge Learning Libraries Mails Maintenance Manuals Marketing Maryland Medical Methodology Methods Modeling Online Systems Pamphlets Performance Periodicals Phase Practice Management Preparation Price Process Product Packaging Publications Published Comment Reaction Time Research Research Infrastructure Research Personnel Resources Running Sales Security Services Simulate Site Solutions Speed Staging Stress Stress Tests Structure System Technology Test Result Testing Time TimeLine Training Training Programs United States Update Work Writing base commercialization cost cost effective data management design experience improved interoperability meetings prevent prototype quality assurance repaired software development tool

项目摘要

DESCRIPTION (provided by applicant): The business of developing, testing, and approving new medical treatments for use in the U.S. has changed dramatically over the past 10 years. In recent years we have observed declining approvals, increasing costs, increasing regulatory process complexity, doubling of the number of new treatments being tested, and slowing of U.S. based recruitment. Together these forces have contributed to a significant increase in time to market for needed therapies. We believe that the current regulatory requirements for conducting clinical trials are preventing small companies from testing many potentially beneficial therapies due to a lack of resources to conduct this testing. A new, simplified, cost effective technology solution is needed that will allow small research organizations to setup and conduct a clinical trial at an affordable price. If this new technology is based on time-tested standard computer driven processes, it will significantly increase the acceptability of data submissions to the FDA and file transfers to partner organizations. Small researchers also tend not to have IT departments or large data centers to run these types of systems. To ensure the solution can be economically deployed, configured and integrated it should be provided through a Web browser using a Software as a Service (SaaS) model with a data model based on Clinical Data Interchange Standards Consortium (CDISC). C-TASC is in a strong position to deliver this technology with a sustainable competitive advantage due to the experience and intellectual capital we have gained through years of managing these types of studies, our experience in developing Web-based technology to manage clinical trials, and our recent addition of technology leadership that has developed similar Web-based SaaS solutions for other large markets. Creation of this technology will enable small research organizations to affordably conduct studies in a manner consistent with FDA standards, would speed many therapies to market and, in some cases, allow a therapy to come to market that would not have been affordable in the past.

描述（由申请人提供）：过去 10 年来，美国开发、测试和批准新疗法的业务发生了巨大变化。近年来，我们观察到批准数量下降、成本增加、监管流程复杂性增加、正在测试的新疗法数量增加一倍，以及美国招募速度放缓。这些力量共同促进了所需疗法的上市时间显着增加。我们认为，由于缺乏进行此类测试的资源，当前进行临床试验的监管要求正在阻止小公司测试许多潜在有益的疗法。需要一种新的、简化的、具有成本效益的技术解决方案，使小型研究组织能够以可承受的价格设置和进行临床试验。如果这项新技术基于经过时间考验的标准计算机驱动流程，它将显着提高向 FDA 提交数据和向合作伙伴组织传输文件的可接受性。小型研究人员也往往没有 IT 部门或大型数据中心来运行这些类型的系统。为了确保解决方案能够经济地部署、配置和集成，应使用软件即服务 (SaaS) 模型和基于临床数据交换标准联盟 (CDISC) 的数据模型通过 Web 浏览器提供。由于我们通过多年管理此类研究而获得的经验和智力资本、我们在开发基于网络的技术来管理临床试验方面的经验以及我们最近增加了技术领先地位，为其他大型市场开发了类似的基于 Web 的 SaaS 解决方案。这项技术的创建将使小型研究组织能够以符合 FDA 标准的方式以经济实惠的方式进行研究，将加快许多疗法的上市速度，并且在某些情况下，允许一种过去无法负担的疗法进入市场。