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More and more small- and medium-sized CROs decide to use OpenClinica® as their EDC system.
OpenClinica® is low-cost, very user-friendly, and allows to import and export ODM files with clinical data and metadata according to the CDISC ODM Standard.
This allows small- and medium-sized CROs to use OpenClinica® as the basis for an end-to-end solution (from protocol to submission).
Until now, small CROs had to buy expensive statistical software, and spend large amounts of money for training people in the use of that software,
in order to be able to generate CDISC SDTM datasets from their clinical data.
SDTM datasets (and the corresponding define.xml) are often required by sponsors as the set of data
that needs to be delivered. So until now, small CROs had to strongly invest in both expensive software as in training in order to be able to satisfy to the requirements of the sponsor.
The SDTM-ETLTM software is a low-cost, extremely user-friendly,
solution for transforming ODM clinical data (such as exported by OpenClinica®) into CDISC SDTM datasets without the need for statistical software.
SDTM-ETLTM has now been extended to support all OpenClinica®-extensions on the exported ODM datasets from OpenClinica®.
A brochure explaining the additional functionality for the use with OpenClinica® datasets can be found here.
Furthermore, as SDTM-ETLTM uses templates based on SDTM in define.xml format,
the generation of a final define.xml containing the metadata for the SDTM datasets is just a matter of a few mouse clicks.
As SDTM-ETLTM essentially uses drag-and-drop and has many wizards, no knowledge of any statistical software language is necessary.
Although the use of the SDTM-ETL software is very intuitive, some of our customers desire to get some training to start working with the software.
In our experience, one day of training usually suffices to make a jumpstart with the software. Such trainings are of course offered by us, usually at the location
of the customer.
A copy of the tutorial, explaining many of the features of the software, and used during trainings, is available on request.
We are currently also developing online training materials
The SDTM-ETL software is available at highly competitive prices. Considerably volume discounts can be obtained. Academic licenses are available at a reduced price.
For more information about licensing options and pricing, please contact us.
OpenClinica® is a trademark of Akaza Research LLC in the United States
and other countries.
XML4Pharma is not a certified partner, reseller, or affiliate
of Akaza Research LLC, and is not certified, approved, or sponsored by
Akaza Research LLC in connection with the installation, operation,
maintenance or support of the OpenClinica® software platform, the
OpenClinica® Enterprise software platform or any other Akaza
products.
