SMARTT COORDINATING CENTER

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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.