CTASC-Clinical Trials Management System

描述（由申请人提供）：在过去的10年里，在美国开发、测试和批准新药物治疗的业务发生了巨大的变化。近年来，我们观察到批准数量下降、成本增加、监管程序复杂性增加、新疗法测试数量翻倍以及美国招募速度放缓。这些力量共同促成了所需疗法上市时间的显著增加。

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. PUBLIC HEALTH RELEVANCE: 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 run a clinical trial at an affordable price. C-TASC is developing this Clinical Trials Management System using Java and AJAX technologies to: enable small research organizations to affordably conduct studies in a manner consistent with FDA standards, speed many therapies to market and allow a therapy to come to market that would not have been affordable in the past.