SMARTT COORDINATING CENTER

最近NHLBI的倡议，以加快科学发现的临床应用进展 包括制定方案，以解决阻碍实现这一目标的特定领域缺乏资源的问题 进步。一个例子是科学走向研究、翻译和治疗(SMARTT) 计划，该计划旨在提供资源，促进治疗实体的发展 各种心脏、肺和血液疾病，将包括一系列服务，包括 药理学/毒理学测试、制造和中央协调职能。协调 中心将整合计划所有组成部分组织的活动，并提供 市场营销、监管和检查支持。RTI国际公司很高兴将这项建议提交给 作为Smartt协调中心，提供高效的沟通流程 所有利益攸关方之间的互动；数据协调/信息技术解决方案，以支持 沟通流程和协调工作流程；监管事务/检查支持，以确保 计划活动符合监管指导方针，并开展积极的营销活动，以 吸引研究人员参与SMARTT计划，从而充分利用计划资源。使用 三十多年来在NIH资助的需要集成数据管理的项目上经过验证的绩效 流程，一个专门从事数据收集和处理各个方面的信息技术团队 监控、广泛的DRG发现/开发和监管专业知识以及出色的市场营销 资源，R TI提供了SMARTT项目成功所需的所有技能和资源。

Recent NHLBI initiatives to accelerate the progression of scientific discoveries to clinical application include the development of programs to address a lack of resources in specific areas that hinder this progress. An example is the Science Moving towArds Research Translation and Therapy (SMARTT) program, which is designed to provide resources to facilitate the development of therapeutic entities for various diseases of the heart, lung, and blood, and wil include an array of services, including pharmacology/toxicology testing, manufactuing, and a central coordinating function. The coordinating center wil integrate the activities of all the component organizations of the program and provide marketing, regulatory, and inspectional support. RTI International is pleased to submit this proposal to serve as the SMARTT Coordinating Center, providing communication processes that result in productive interactions among all stakeholders; data coordination/information technology solutions to support these communication processes and to coordinate workflow; regulatory affairs/ inspectional support to ensure that program activities are compliant with regulatory guidelines, and a proactive marketing campaign to attract research investigators to the SMARTT program and thereby fully utilize program resources. With over three decades of proven performance on NIH-funded projects requiring integrated data management processes, an information technology team that specializes in all aspects of data collection and monitoring, extensive drg discovery/development and regulatory expertise, and excellent marketing resources, R TI offers all of the skils and resources required for the success of the SMARTT program.