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Our concept is to offer you a certain basic functionality for a very reasonable price (some of our tools are even free for CDISC members).We do however offer to adapt the software to your companys needs and requirements, and if requested, deliver it as a plugin (including documentation) (e.g. More information about these tools, pricing, our tailoring services, etc.., can be obtained from here.It uses XML-Schema and Schematron (an "open rule" validation language) - the user can even switch on and off rule separately.The software has been shown to be much better that the validator that is normally used by the FDA and PMDA (the latter reporting very many false positives).The data are visualized as HTML tables with easy navigation through the whole contents of the ODM file.The ODM Viewer also allows to tabulate subsets of the data, e.g.As such, it is an indispensable software package for every sponsor that is submitting information to the FDA and PMDA using the standard, also as it allows to distinguish real conformity problems from false positive errors generated by the FDA and PMDA tools.More about the CDISC Checker The ODM Viewer is the first tool on the market to visualize CDISC ODM 1.2 or 1.3/1.3.1 files in a very user-friendly way.
Our tools are "take it or leave it" products, at the contrary.The tool is extremely user-friendly: the user never needs to see any XML.The tool connects ODM and with SDTM: it knows everything about SDTM domains and variables of SDS 1.1 to 1.4 (SDTM-IG 3.1.1 to 3.2). 2016 The Define-XML Standard is one of the most established standards of CDISC, and also one of the most important, as it is required to be submitted by regulatory authorities such as the FDA and the PMDA.Both these tools have been implemented as server-side tools (you can already use them free-of-charge at our application server), but they can also be made available as standalone applications (as Java application or Windows executable).The XML version of the CDISCLab Checker has already been implemented at one of our North American customers: it allows checking of all CDISC Lab files that are located on the server, and generates a validation report, and a log report (for 21CFR-11 reasons) for each of them.