OCTAGON ANNOUNCES SUBMISSION STEWARDSHIPTM PROGRAM
KING OF PRUSSIA, PA - February 14, 2005 - Octagon Research Solutions, the leader in the electronic transformation of clinical R&D, today announced the introduction of the Submission StewardshipTM Program, an innovative outsourcing model that supports the production and maintenance of a Regulatory Submission across the submission lifecycle.
The program is designed to provide complete submission capabilities to pharmaceutical and biotechnology companies who are facing the challenges of producing compliant submission output, including eCTD (Electronic Common Technical Document) format.
Nancy Smerkanich, vice president of Regulatory Affairs commented, "This offering evolved in response to the industry need for knowledge, experience and long term capabilities that support the eCTD. Many of our clients have made the strategic decision to implement the eCTD but don't have the bandwidth or internal expertise to support this as an ongoing endeavor. The nature of eCTD and lifecycle management is forcing companies to shift from a project to a process outsourcing perspective."
The eCTD is an initiative devised by the International Conference on Harmonization (ICH) that specifies a common format for the transmission of regulatory submission information to global health authorities. The requirement specifies document and data formats and introduces XML as a critical component of the submission.
James Walker, president and CEO of Octagon, commented, "The Submission Stewardship Program reflects the changes that are occurring in industry. Because of our cross-functional approach and our practical experience, Octagon is uniquely positioned to offer a novel and comprehensive service offering that will lighten the burden for those companies that are taking on the challenges of implementing eCTD."
Under the Submission Stewardship Program, the organization, compilation and delivery of investigational application, market applications and all corresponding maintenance submissions (in multiple formats) are outsourced to Octagon, spanning the entire submission lifecycle.
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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