Our industry has a real need for a cost-efficient solution to convert legacy clinical data to CDISC, not only to meet the FDA requirements, but also facilitate data exchange and readability
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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 the SDTM mapping needs of medical device companies,” explains Ale Gicqueau, President & CEO at Clinovo. “Our industry has a real need for a cost-efficient solution to convert legacy clinical data to CDISC, not only to meet the FDA requirements, but also facilitate data exchange and readability”. CDISC has been downloaded over 900 times since its launch mid-2011, by leading fortune 500 sponsor companies, as well as the Food and Drug Administration (FDA) and the Clinical Data Interchange Standards Consortium (CDISC) organization.
Clinovo recently signed a contract with a world leading nutrition and health company. Clinovo will provide SDTM conversion services and in-depth trainings including hands-on labs and application of knowledge using the clients’ own clinical data. Clinovo is a trusted CDISC® Registered Solutions Provider as well as Gold Member of the CDISC organization. The company has years of experience delivering SDTM conversion, training, and support services to pharmaceuticals and medical devices companies in the US and Europe. Clinovo also partners with CROs willing to help their clients make the move to CDISC standards.
Clinovo is also launching an 8-week evening class on CDISC standards to meet the growing demand by sponsor companies to build their internal expertise. The CDISC Standards: Theory and Application class is part of Clinovo’s TechTrainings and provides in-depth understanding of ODM, SDTM, ADaM and Define.XML. Students will learn through examples how to transform legacy data into CDISC standards. The use cases will include exchanging data, archival, and electronic submission to regulatory agencies such as the FDA submission. Visit clinovo.com/cdisc-techtrainings for details and registration.
Clinovo partners with life science companies to streamline their clinical trials, leveraging years of expertise in systems integration, open-source technology, and industry standards. Clinovo provides staffing solutions, eClinical systems, and Biometrics Services including Clinical Data Management, Electronic Data Capture, CDISC Mapping, and Clinical and Statistical Programming.
CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website.