OCTAGON ANNOUNCES STRUCTURED PRODUCT LABELING (SPL) STEWARDSHIP OFFERING
WAYNE, PA - June 27, 2005 - Octagon Research Solutions, the leader in the electronic transformation of clinical R&D, today launched their Structured Product Labeling (SPL) Stewardship Program, a comprehensive service offering that includes training, implementation consulting and conversion services for the biopharmaceutical industry. Simultaneously, the company also announced the selection of ThinSpring’s SPL Server as the conversion technology that will be utilized in the SPL Stewardship Program.
Octagon’s SPL Stewardship program was designed to support the industry’s transition to SPL. A Food and Drug Administration Final Rule issued Dec 11, 2003 and effective June 8, 2004 requires submission of the content of labeling in electronic format. The agency is expected to begin enforcing the requirement to submit content of labeling in an SPL format in October 2005. This format is a standard for describing content of labeling in an XML (eXtensible Mark-up Language) document.
ThinSpring is the leading provider of XML Web service solutions, integration and data conversion services. SPL Server is a thin client XML editor designed for the management of SPL.
Jim Walker, president and CEO, Octagon Research Solutions, commented, “The Structured Product Labeling initiative is yet another electronic standard that has the potential to save time, money and resources across the industry. The early implementation of the standard will result in significant and recurring savings as content is reused across a product lifecycle. Octagon’s process knowledge and industry expertise powered by the strong technology solution that SPL Server offers, will catapult early adopters into a new wave of competitive advantages.”
Ron Celeste, president and CEO, ThinSpring noted, “SPL is the first of many XML-based standards that will transform the way we do business. The implementation of innovative technologies to support this transformation will be the key to success. Octagon’s Submission Stewardship Program is a perfect application of SPL Server’s novel technology that will benefit our mutual client base and provide a strong foundation for the successful implementation of SPL.”
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 King of Prussia, PA, with an office in Boston, MA. For more information please visit www.octagonresearch.com.
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