Abstract
Clinical trials involve multi-site heterogeneous data generation with complex data input-formats and forms. The data should be captured and queried in an integrated fashion to facilitate further analysis. Electronic case-report forms (eCRF) are gaining popularity since it allows capture of clinical information in a rapid manner. We have designed and developed an XML based flexible clinical trials data management framework in .NET environment that can be used for efficient design and deployment of eCRFs to efficiently collate data and analyze information from multi-site clinical trials. The main components of our system include an XML form designer, a Patient registration eForm, reusable eForms, multiple-visit data capture and consolidated reports. A unique id is used for tracking the trial, site of occurrence, the patient and the year of recruitment. http://www.rfdn.org/bioinfo/CTMS/ctms.html.
Highlights
Conducting clinical trials using defined protocols and and drug discovery process
We have designed and developed an XML based flexible clinical trials data management framework in .NET environment that can be used for efficient design and deployment of Electronic case-report forms (eCRF) to efficiently collate data and analyze information from multi-site clinical trials
Each trial (CTMS), Electronic Data Capture (EDC) and other requires several hundred pieces of data to be compiled at specialized clinical study solutions intended to reduce the the end and further processed for statistical analysis
Summary
Conducting clinical trials using defined protocols and and drug discovery process. Organizations use variety of reporting data regarding safety/efficacy is considered to be applications like Clinical Trial Management Software the bottle-neck in drug development process. CliniProteus: A flexible clinical trials information management system
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