OCTAGON RESEARCH SOLUTIONS AND WEBCLIN PARTNER TO PROVIDE CDISC TRAINING
KING OF PRUSSIA, PA - July 26, 2004 - Octagon Research Solutions, the leader in the electronic transformation of clinical R&D, and Webclin, a consulting services provider specializing in data standards for electronic submissions, announced today that the two organizations are partnering to provide CDISC Training to the biopharmaceutical industry.
Through the partnership, Octagon and Webclin have designed a comprehensive training program that will focus on familiarizing organizations with CDISC data standards and assisting those organizations to support the implementation of CDISC standards. The initial offering will focus on the SDTM (Study Data Tabulation Model) version 3.1.
"Transitioning an organization to CDISC Standards will be a complex activity," said Jane Boone, president and CEO of Webclin. "The implementation of these data standards will have a significant impact on electronic submissions. For this reason, Webclin and Octagon have chosen to be active members in CDISC, intimately involved in the development of CDISC standards. We are committed to facilitating the adoption of CDISC standards through practical training programs that take advantage of our combined expertise."
"This partnership is particularly significant in light of the recent Study Data Specification, published by the Food and Drug Administration," said Tom Guinter, vice president of Clinical Information Management at Octagon. "The implementation of CDISC standards just became a reality for many organizations that have already committed to electronic submissions. Our combined expertise in developing and conducting industry training programs and executing clinical and regulatory activities to support electronic submissions, uniquely qualify us to lead this initiative and offer our clients expert guidance."
The document titled, "Study Data Specifications", that references these new standards was published by the Food and Drug Administration on July 21, 2004 on the CDER eCTD web page.
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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