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
kTrials™ provides easy-to-use, affordable Electronic Data Capture(EDC) for data collection in clinical trials. Our EDC system is 21 CRF Part 11 compliant and full hosted on cloud. 'With kTrials' study manager can easily build studies without programing knowledge. Plus kTrials costs 80% less than the traditional EDC solutions. The system have library were user can select without creating new fields, panel.
Full Scale Clinical Trial Management System (CTMS) Module
kTrials™ supports project management, teams to keep oversight about large trials. It controls budgets, investigator fees, milestone, timeline, enrollment summaries and responsibilities. It gives automatic instruction and guidance to clinical monitoring team who can report offline onsite information during site visit.
eTMF (Electronic Trial Master File) Module
The capability to store documents related to trial. The system may offer simple document storage or may have advanced document management features such as document versioning and workflow.
SDTM Mapping Module
kTrials™ transforms CDISC ODM datasets with clinical data into SDTM dataset. It is easy to use mapping software package for defining and executing ODM to SDTM mapping.
System Reports & Dashboards
kTrials™ software application offers various standard reports. System prepare your reports with real-time data to analyze trends, find discrepancies and monitor site compliance. Built-in Audit trial function is unique reporting tool to keep track of your study at any time.
Interactive Web Response System(IWRS)
kTrials™ uses the latest statistical methods, programming and validation procedures. This insures quick, accurate, valid and balanced subject assignment; The IWRS functionality completely manages the supply chain from shipment to re-supply thus ensures proper kit number and the monitoring of defective or damage supply. System easily manages randomization, subject enrollment and drug supply management in the clinical trials.
In recent years Ad-Hoc reporting has become a must have feature, allowing users to create their own reports. The best of these systems will allow reports created for one study to be easily used in other study.
System provides some methods to perform medical coding activities with standard dictionaries such as MedDRA and WHODD. The best of these systems will provide auto coding facilities. Allow dictionaries to be loaded and synonyms lists to be managed.
System provides an integrated method to perform randomization (using various algorithm) which may be more convenient for user in some situation then a IVRS and computer EDC system.