Clinical and Multisite Studies
We specialize in the data coordination of multisite research studies in which multiple institutions implement the same research protocol simultaneously across domestic and international sites. Since clinical trials and a variety of other large research studies depend on the rigorous implementation of protocols across multiple institutions, these types of projects present unique technology challenges.
To meet these, we support a wide spectrum of clinical and behavioral research, supplying flexible methods for data acquisition and management for all types of data, including survey, clinical, medical measurement, and laboratory specimens. Our data coordination systems are custom-designed to meet the specific research requirements of each project while providing appropriate security features for the specific effort. Methods of acquisition include in-person and self-interviewing, extensive use of mobile computing devices, and the web-based RAVE® system by Medidata for validated studies.
Capabilities
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Electronic data collection systems developed for participating research sites, including deployment of validated systems for clinical trials
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Study Web portals with role-based security for data entry, data queries, and other features
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Automated data validation processes such as range and consistency checks
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Stringent testing and documentation procedures to ensure high-quality software components through an established System Development Life Cycle
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NIST-compliant data security systems validated for handling personally identifiable health information
Focus Areas
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Maternal and child health
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STD/HIV research
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Forensic medicine
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International studies
Projects
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Data Coordinating Center for the Neonatal Research Network (NICHD, 1998–2013). Provide Web portal and data management services for 16 U.S. hospitals engaged in clinical trials and observational studies.
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National Forensic Laboratory Information System (Drug Enforcement Agency, 2008–2013). Collect, standardize, and integrate disparate data sets from hundreds of forensic laboratories across the U.S. to study trends in controlled substance use.
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Global Network for Women's and Children's Health Research (NICHD, 2001–2012). Support multiple protocols for international network of 10 research units dedicated to reducing morbidity and mortality among women and children globally.
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State Outcomes Measurements and Managements Study (SAMHSA, 2005–2009). Provide support to develop and implement a system for measuring substance abuse and mental health treatment and prevention success, using a core set of National Outcome Measures (NOMs).