CTASC-Clinical Trials Management System

描述（由申请人提供）：在过去10年中，开发、测试和批准在美国使用的新医疗方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，监管过程复杂性增加，正在测试的新疗法数量增加了一倍，美国招募速度放缓。这些力量共同促成了所需疗法上市时间的显著增加。 我们认为，目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的有益疗法，因为缺乏进行这种测试的资源。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负担得起的价格建立和开展临床试验。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，它将大大提高向FDA提交数据和向合作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浏览器提供解决方案。 C-TASC在提供这项技术方面处于有利地位，具有可持续的竞争优势，这是由于我们多年来管理这些类型的研究所获得的经验和智力资本，我们在开发基于Web的技术来管理临床试验方面的经验，以及我们最近为其他大型市场开发类似的基于Web的SaaS解决方案的技术领导地位。 这项技术的创建将使小型研究组织能够以符合FDA标准的方式进行研究，加快许多疗法的上市速度，并在某些情况下，允许过去无法负担的疗法进入市场。

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.