Clinical trials involve multi-site heterogenous 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 a .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 occurence, the patient and the year of recruitment.

Some of the features of CliniProteus are:

• End user administration
• Patient registration
• eCRF
• Verification if eCRF data entry
• Maintain inclusion/exclusion criteria, adverse event log
• Visit management
• Shipping and handling of samples
• Clinical sample data integration
• Customized reports
• Research analysis