CSS Informatics Offers First Commercially Available Software Designed Specifically for Converting Oracle® Clinical Data to New CDISC SDTM 3.1 Format
PPD, Inc. (Nasdaq: PPDI) today announced CSS Informatics, the clinical and safety data management consulting services and proprietary e-technologies division of PPD, has released OC2SDS, the first standardized and validated software that converts Oracle® Clinical data to submission-ready data sets that follow standards recently adopted by the U.S. Food and Drug Administration (FDA). PPD is a partner member of the Oracle PartnerNetwork.
OC2SDS provides an electronic gateway for converting Oracle Clinical data to SAS version 5 transport files formatted according to the Clinical Data Interchange Standards Consortium (CDISC) study data tabulation model (SDTM) version 3.1 selected by the FDA as the format for sponsors of clinical trials to use when submitting data to the agency.
“OC2SDS can significantly increase the efficiency of clinical data submission preparation by handling the complexities and defined structures of the CDISC model,” said Larry Kaufman, vice president of CSS Informatics. “Companies preparing submissions using Oracle Clinical will benefit from incorporating OC2SDS software as it provides structure and objects that are reusable in preparation for future submissions. OC2SDS replaces custom software solutions that require regular revisions, upgrades and revalidations.”
The software offers both simple and advanced technology for converting Oracle Clinical data to the CDISC format. OC2SDS provides utilities to map one or more source views to a single target CDISC domain, create new views for mapping, convert items using built-in functions, create new target clinical domains and map Oracle Clinical discrete value groups to controlled CDISC terminology. Completed mappings can be executed to produce submission-ready CDISC-formatted data sets along with the required define.xml metadata file. The system self-audits and can produce reports on mappings performed. The ability to reuse mappings across clinical studies is built into the software allowing for item mappings to be added to the user’s OC2SDS data dictionary for reuse and copied to new studies.
As a leading global provider of discovery and development services and products for pharmaceutical, biotechnology and medical device companies, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients maximize the return on their R&D investments. With proven early discovery through post-market resources, the company also offers compound partnering opportunities. PPD has more than 6,600 professionals in 27 countries around the world. For more information on PPD, visit our Web site at http://www.ppdi.com .
