Welcome To CodeAngelo™
CodeAngelo™ 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.
CodeAngelo™ eclinical suite offers
Full Scale Electronic Data Capture (EDC) / Paper Data Capture (PDC) Module
CodeAngelo™ 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 CodeAngelo' study manager can easily build studies without programing
knowledge. Plus CodeAngelo 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
CodeAngelo™ 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
CodeAngelo™ 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
CodeAngelo™ 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)
CodeAngelo™ 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.
Ad-Hoc Reporting
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.
Medical Coding
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.
Randomization
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.