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Agati’s solution to present the metadata of the clinical trial data, that is being submitted to the agency, in Define.XML structure as per CDISC standards. DefineBot significantly reduces the time to create define.xml by automating the Origin, CodeLists, Controlled Terminologies, Value Level Meta Data and WhereClause sections of define.xml as per submission standards.


DefineBot’s advantages are:

  • 21 CFR Part 11 Compliance

  • Built-in validation rules to ensure CDISC standards compliance

  • NCI CT updates and standards metadata uploads

  • Built-in XML schema validator

  • Origin identification, code lists and NCI CTs are automated for efficiency

  • Define.xml in hours not in days or weeks



Agati team has leveraged our expertise in clinical data standards and technology to build TransBot solution that automates and accelerates the data transformation of non-standard clinical data into a standard format like SEND, SDTM and ADaM. TransBot offers metadata driven automation that complies with 21 CFR Part 11 regulatory guidance and industry standards like CDISC.

TransBot has the following advantages:

  • Metadata driven end-to-end transformation

  • Internet browser-based User Interface

  • Data and documents in central repository

  • Visual transformation blocks

  • Standards compliance with CDISC ODM/SEND/SDTM/ADaM/Define.xml

  • Multiple data source formats XLS, CSV, XPT, ASCII delimited text

  • Annotations, source/target metadata and data views in UI

  • Updates to standards and custom standards through metadata management

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