OCTAGON SELECTED BY PROCTER & GAMBLE PHARMACEUTICALS AS CDISC SDTM CONVERSION PARTNER Domain Expertise and Innovative Technology Power Conversion Strategy
Wayne, Pa. – October 11, 2005 – Octagon Research Solutions, the leader in the electronic transformation of clinical R&D, today announced that the company has been selected by Procter & Gamble Pharmaceuticals to convert legacy data from six clinical studies to the CDISC (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation Model) format. The CDISC SDTM is a standard for the submission of electronic data from human clinical trials that is now being accepted by the U.S. Food and Drug Administration (FDA).
As part of its transition strategy for implementing the CDISC SDTM, Procter & Gamble Pharmaceuticals evaluated potential partners to address their legacy-data conversion needs. Fred Wood, Ph.D., Global Data Standards manager, Procter & Gamble Pharmaceuticals, indicated that Procter & Gamble Pharmaceuticals is committed to implementing the CDISC SDTM for current and future studies. He added that in order to minimize the impact on current resources, Procter & Gamble Pharmaceuticals selected a partner who offered significant domain knowledge, efficiency, accuracy and compliance throughout the conversion process. These factors are important given the significance of the data.
Tom Guinter, vice president of Clinical Data Strategies at Octagon, noted, “Our conversion methodology is powered by our internal SDTM expertise and use of the SAS® Enterprise ETL Server to automate the conversion process. This approach allows us to couple our standards- and process-based philosophies throughout the conversion process, ultimately resulting in higher-quality deliverables for our clients.”
The implementation of the SAS Enterprise ETL Server for this application is unique in the industry. Ed Helton, Ph.D., SAS’s chief strategist of regulatory and biomedical affairs, noted, “Octagon is delivering on the promise of automated electronic processes. By utilizing the SAS Enterprise ETL Server, they are taking advantage of opportunities to provide extended value to clients who are taking on the challenges of implementing new data standards.”
About Octagon Research Solutions, Inc.
Octagon is a leading process-centric solutions provider that offers a suite of regulatory, clinical, process and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. We leverage the power of electronic submissions through cross-functional eSub expertise, a holistic process approach, deep domain knowledge and creative use of technology. Octagon is headquartered in Wayne, PA, with offices in Boston, MA, and Costa Mesa, CA and European Headquarters in Amersham, UK. For more information please visit www.octagonresearch.com.
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