Clinical Trial Management Overview
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Broad Expertise
Supporting a portfolio of multi-center clinical trials requires extensive oversight and coordination to maintain integrity and reliability of their results. A strong and high functioning central clinical trials coordinating center, with a high level of expertise and experience, is the cornerstone for supporting successful clinical trials. In order to accomplish the goals of a network, there is clearly a need for support, including logistical infrastructure and data management, scientific, statistical, and administrative expertise.
Without strong, experienced, and proven support on all these fronts, research results would be more difficult and costly to obtain, less reliable, less reproducible, and less easily disseminated. The CTDD brings all of this expertise through our core range of functional services and our team members.
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Promote a Culture of Innovation Across All Functional Units
Innovation is critical not only for efficiency improvements recognized by end users and developers but also for maintaining talent. The CTDD maintains a culture of innovation for staff engagement and retention, to strive for quality improvement and contribute to trial reliability, safety and integrity through increased efficiency. Innovations supporting NCTN clinical trials developed by CTDD staff cover areas of operational efficiency, quality assurance, statistical design, Medidata Rave® study build and quality management systems.
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Guided by a Robust Library of Standard Operating Procedures and Policies
A proprietary on-line SOP system was created to manage documents, on-line authoring and training. This system has been used by the CTDD and for NRG Oncology SDMC SOP management.