Sunnyvale, CA (PRWEB) August 27, 2013
Clinovo releases CDISC Express 1.1, a new version of its free for download SAS®-based CDISC SDTM mapping eClinical system. Downloaded over 900 times since its launch mid-2011, the software automatically converts clinical data into CDISC SDTM using an Excel framework. CDISC Express includes the automatic creation of Define.XML, a generic SDTM validation tool, as well as an advanced lab module.
The 1.1 release of CDISC Express follows the new SDTM 3.1.3 specifications. The existing domains have been upgraded with more comprehensive variables. Seven new medical device domains have also been added from the new SDTM medical device guide released by the CDISC organization. New features include a new format catalog upload function to avoid error-prone and time-consuming data-entry steps. Validation checks have been enhanced and made more comprehensive.
Case studies showed that SDTM mapping using CDISC Express accelerates the conversion by up to 4 times. Use of CDISC is proven to save up to 60% in non-subject participation time and cost. It speeds up data-review and improves clinical data exchange, storage and archival. CDISC SDTM conversion ensures data integrity and consistency, and allows submitters to find out discrepancies before the FDA submission. A submission under SDTM standards is thus twice faster than without SDTM. Three FDA submissions out of five are already done in CDISC standards. It will be mandatory for pharmaceutical companies by 2016.
“CDISC Express is perfectly up-to-date with the latest CDISC requirements, and is now compatible with
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