kTrials™ is Karmic’s proprietary, 21 CFR Part 11, CDASH/CDISC and SDTM Compliant, Web-Enabled eClinical Suite with integrated Clinical Trial Management, Clinical Data Management, Electronic Trial Master File, SDTM Mapping, Clinical Data Warehousing and Operational Analytics functionalities designed especially to support Karmic’s end-to-end Global Clinical Operations, Data Management and Project Management requirements. The system supports end-to-end operational activities from project set-up, planning, budgeting, execution, performance analytics and reporting for all clinical trial, apart from storing all clinical and operational enterprise data as well as electronic trial master files in a single repository.
kTrials™ eclinical suite offers
- Full Scale Electronic Data Capture (EDC) / Paper Data Capture (PDC) Module
- Full Scale Clinical Trial Management System (CTMS) Module
- eTMF (Electronic Trial Master File) Module
- SDTM Mapping Module
- System Reports & Dashboards
- Interactive Web Response System(IWRS)
- Ad-Hoc Reporting
- Medical Coding
- Randomization
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