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One of KAI's strengths includes its data management expertise. KAI staff members
have developed software applications such as its clinical data management system
(CDMS), Smart Study©™,
which supports eCRFs. With eCRFs, study sites transmit data using application hosting
technology in an internet environment. This CDMS allows for real-time data editing
and study management which is not only cost-effective but an efficient use of resources.
Smart Study©™ interfaces
with the KAI interactive voice recognition system (IVRS) for use in treatment assignment
and medical coding dictionaries.
Smart Study©™ complies
with 21 CFR Part 11 requirements and allows rapid startup of studies, extensive
editing and direct access by SAS for analysis, and facile report preparation. Our
clients appreciate this cost-effective and efficient approach to real-time editing
with an added level of assurance that data generated meets KAI’s established
standards for quality and integrity. In 2006-2007, Smart Study©™
supported 37 studies conducted at hundreds of sites sponsored by both industry and
NIH. Smart Study©™
can also support paper CRFs which are centrally housed and maintained by KAI staff.
KAI is also developing common data elements that can facilitate the storage of an
organization’s completed study data and for building a data warehouse. Data
warehouses facilitate aggregate data exploration and analyses. Please refer to Data
Warehousing section of the website for more information on our data warehousing
capabilities.
Fact Sheet
Clinical Data Management
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