DATA News .39 DATATRAK Expands CDISC Registered So
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DATA News .39 DATATRAK Expands CDISC Registered Solutions Provider Standards
2012-06-19 07:30 ET - News Release
Define.XML Certification Completed
CLEVELAND, June 19, 2012 /PRNewswire/ -- DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced that it received Registered Solutions Provider Status for Define.XML. This registration increases DATATRAK's total to five - CDASH, LAB, ODM, SDTM and Define.XML.
Define.XML is an XML-based submission of the study's metadata. The Define.XML file provides Case Report Tabulations Data Definitions in an XML format for submission to regulatory authorities (e.g., FDA). This list of the datasets included in the submission also provides a detailed description of the contents of each dataset.
"As a longstanding member of the CDISC Advisory Board, DATATRAK's certification on another CDISC standardization is especially gratifying," stated Chris Wilke, DATATRAK's Chief Technology Officer. "The completion of this new status exemplifies our leadership in cloud-based unified clinical research technology and our support of standards. It also re-enforces DATATRAK's continued commitment to provide new methods for increasing customer productivity and satisfaction."