CDISC (Clinical Data Interchange Standards Consortium) has been establishing new non-proprietary clinical data standards to speed up data-review and improve clinical data exchange, storage and archival. We have experience in CDISC implementation and CDISC data production.
Clinical data of increased complexity come from multiple sources and in variable formats. We offer consulting services for mapping of the various data structures into the standard structures, supported by own developed process tool.
We offer automatic creation of SDTM datasets and Data Definition File inclusive quality management, supported by our Oracle-based conversion tool.
We offer automatic creation of ADaM datasets and Data Definition File according to the SAP inclusive quality management, supported by our Oracle-based conversion tool.