NHLBI-Clinical Data System (CDS)

Client Situation
The National Heart, Lung, and Blood Institute (NHLBI)
Division of Intramural Research (DIR) and Office of Biostatistics Research (OBR)—needed to more effectively manage their clinical trials data, patient data, and research outcome data in studies related to heart, lung, and blood diseases. In particular, staff within both divisions needed to efficiently access, disseminate, and share clinical data across concurrent clinical operations. Three specific branches of research—Hematology, Cardiovascular, and Pulmonary-Critical Care—called for the implementation of a web-based clinical database system.

Solution: The NHLBI Clinical Data System (NHLBI-CDS)
CTIS, Inc., partnered with Digital Infuzion to develop and implement a highly scalable, robust, web-based Clinical Data System (CDS). From protocol development to patient registration to quality assurance monitoring, the components of the CDS provided full capability for web-based clinical trial data management, as well as integration with mobile devices such as PDAs for remote data entry and access.

During the project, we used an existing custom-developed application, CTIS’s TrialBridge™, an architectural framework on which specific workflows and functional requirements could be built and expanded. This approach offered comprehensive functionality tailored to the needs of the DIR and OBR.