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CDISC
(Clinical Data Interchange Standards Consortium) is establishing standards for exchange, storage, submission and archival of clinical data.
The most important of these standards are the ODM (Operational Data Model), for the archival and exchange of clinical data between sponsors, CROs and Data Management Companies, and the SDTM (Submission Data Model), with two implementations and corresponding Implementation Guides: SDTMIG (for human clinical studies) and SEND (for non-clinical / pre-clinical studies)
Other standards are Lab (exchange of laboratory data), Define-XML and ADaM (Analysis Dataset Model).
The ODM, Lab and Define-XML standards are currently implemented using XML as the format.
A new standard is Dataset-JSON which is expected to soon replace SAS Transport as the format for submissions to the regulatory submissions such as FDA, PMDA and NMPA.
XML4Pharma has developed a number of software tools for working with CDISC ODM, Lab, SDTM/SEND and Define-XML standards.
These products are especially interesting for Sponsors, CROs and Data Management Companies, as they
save considerable time and money when working with the ODM and Lab standards and on regulatory submissions (SDTM/SEND). Some of these can also be incorporated into the products of technology vendors.
Our tools are not "take it or leave it" products, at the contrary. Our concept is to offer you a very high-level functionality for a very reasonable price (some of our tools are even free for CDISC members). We do however also offer to adapt the software to your company´s needs and requirements, and if requested, deliver it as a plugin (including documentation).
More information about these tools, pricing, our tailoring services, etc.., can be obtained from here.
These products are complementary to the consultancy services
we deliver to Sponsors, CROs, Data Management Companies, and Clinical Technology Vendors.
However, in most cases, you will not need additional consultancy services to start working with our software tools, as they come with full documentation, and usually very user-friendly and self-explaining.
Allows to generate or refine Define-XML files starting from scratch, templates (delivered for every SDTMIG and ADaMIG version), from CDISC submission datasets, or from a "raw" define.xml exported from SDTM-ETL, in a very user-friendly way. This software is much better than what the competition (especially P21 Community) offers! |
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| The ODMViewer (NEW Version 1.6 available) | The CDISC ODM Checker | The CDISC ODM Generator |
| The CDISC Lab ASCII to XML Converter | The CDISC Lab Checker (ASCII or XML implementation) | The ODM Reporter (PDF generator) |
SDTM-ETLTM is a very user-friendly, visual software package to design and create mappings between CDISC ODM and CDISC SDTM,
and to execute these mappings on your clinical data, generating SDTM or SEND datasets.
The software also allows to create an SDTM/SEND database in which the generated SDTM records can be stored.
Furthermore, the corresponding define.xml file is generated simultaneously.
The Define-XML Designer is a software product to design, develop and refine define.xml files either from scratch, from templates (which are delivered for every SDTMIG/SENDIG and ADaM versions) and starting from prior define.xml files (reuse),
or from already generated CDISC submission files (SDTM, SEND and ADaM). Unlike other tools, it is extremely user-friendly,
with a large amounts of wizards. During the generation, it continously allows to validate the define.xml file that is being developed (it does this in a much precise way than the software that is used by the FDA for validating define.xml files, the latter giving a lot of false positives).
The newest version now also has an addtional near-WYSIWYG interface.
This software is surely 1000 times more user-friendly than one what Pinnacle21 Community offers, which is still used a lot for generating define.xml files.
More about the Define-XML Designer
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.
The CDISC Define.xml Checker is a software package to validate your define.xml files against the standard and for internal consistency.
The software has been developed by Jozef Aerts, one of the main developers of both the define.xml 1.0 as 2.0 standard, and one of the most knowledgeable people concerning the Define-XML standard in the world.
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).
As such, it is an indispensable software package for every sponsor that is submitting information to the FDA and PMDA using the define.xml 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 Define.xml 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.
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. all Demographics data of Subjects 1, 3, 7-10 where the Investigator was Jane Doe.
More about the ODMViewer (including screenshots)
The ODM Generator is a utility tool to transform "flat" data files (CSV, bar-delimited data files, exports from Excel, ...), SAS Transport 5 or sas7bdat files
into CDISC ODM files, including the generation of the metadata.
It is especially useful in combination with the SDTM-ETL software when part of the data (such as lab data)
is not available as CDISC ODM files.
It also allows to merge ODM files from different sources into a single ODM file (ODM Merger).
The CDISC ODM Checker takes a CDISC ODM file and checks it for well-formedness and validity against the DTD or XML-Schema
and (even more important) against the published standard (features that could not be incorporated into the DTD or Schema).
This includes checking for consistency of the data (e.g. ClinicalData against Study MetaData).
If a violation against the standard is found, the application explains in well understandable language what is wrong,
and gives good suggestions for reparing the violation.
This application is available for free to CDISC members.
It can also be made available as a module for incorporation into other software (on commercial basis).
More about the CDISC ODM Checker (including screenshots and demos)
This tool allows to transform CDISC Lab files in bar-delimited ASCII format into CDISC-Lab XML format. As such, this tools allows CROs that obtain Lab files in ASCII format to convert it into a better machine-readable format, and then to transform the Lab data into ODM format, and/or to store the Lab data in native XML databases.
More about the CDISC Lab ASCII to Lab XML Converter
The CDISC Lab Checker is a tool for checking CDISC Lab files, either in XML format or in ASCII format, against the standard.
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 CDISCLabChecker has already been implemented at one of our NorthAmerican 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.
This ensures them that they really work CDISC-compliant.
More details about their implementation will soon be published.
This is a tool for on-the-fly generation of reports (in PDF) format from an ODM file.
The user can select which items of the ODM will be included in the output PDF file. Examples of generated
reports of an early version of this reporting system can be found on our web page about "transforming XML data
into PDF presentation".
More about the ODM Reporter (including screenshots)
Do you need another tool for working with the CDISC set of standards ?
We have an enormous amount of experience with the CDISC ODM standard, and a good amount of experience with the XML implementation of the Lab standard.
Furthermore, we are very experienced in designing and developing software for working with XML, mostly in Java, but also in Perl (CGI), PHP, C++.
So, if you need a tool to work with CDISC standards, or need advice for developing such tools or systems, do not hesitate to contact us.
