DefineBot is our homegrown one-stop 21 CFR part 11 compliant software suite that assists the user in creating an error free, completely validated Define.xml for SDTM, ADaM data in compliance with the CDISC standard.
DefineBot provides the user an efficient, time saving & cost effective interface for generating a CDISC compliant Define.xml for SDTM and ADaM clinical studies.
- The software provides multiple user access with privileges for individual users configurable by the admin thereby acting as an effective task management system
- Supports CDISC compliant SDTM version 3.1.2, 3.1.3, 3.2
- The software is futuristic, with minimal inputs the upcoming CDISC standards could be fed in without the need for any updates or patch releases
- The tool helps in finding coded values and coded terms from the in-built NCI code list.
- Creates a complete package that is submission ready
- Performs FDA compliant data validation checks
- Complete audit trial with user information, reason of change and date of update
- Auto update of study data when input files are updated
- Automation helps in generating majority of user input with minimal information required from the user
- The tool produces an error report along with the Define.xml output by performing in-built checks thereby assisting the user to create an error free compliant Define.xml
- DefineBot reads the CRF and locates the CRF page numbers automatically thereby eliminating manual search.
- Attractive and Intuitive UI design
- Requires minimal training for the user to generate Define.xml from source files
- No dependency on other proprietary software