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CEO Chairman Jim Walker of Octagon Research Solutions, Inc., a provider of breakthrough software and services to the life sciences industry, today announced that Summit Drug Development Services, LLC has chosen both ViewPoint and StartingPoint to facilitate submission document authoring and integrated electronic regulatory submission management.
Summit Drug Development Services, LLC Selects Octagon Technology to Power Their Innovative Services
Summit chooses ViewPoint® and StartingPoint® as technology foundation
(WAYNE, PA, August 1, 2008) — CEO Chairman Jim Walker <http://www.octagonresearch.com/management-team.html> of Octagon Research Solutions, Inc. <http://www.octagonresearch.com/> , a pioneer and leading provider of breakthrough software and services to the life sciences industry, today announced that Summit Drug Development Services, LLC has chosen both ViewPoint® <http://www.octagonresearch.com/viewpoint.html> and StartingPoint® <http://www.octagonresearch.com/starting-point.html> to facilitate submission document authoring and integrated electronic regulatory submission management.
Summit Drug Development Services, LLC is a company that accelerates the drug development process by providing high quality strategic focus and tactical implementation of preclinical, clinical, regulatory, and CMC services to the pharmaceutical and biotechnology industry. “The integration of document authoring tools and electronic submission capabilities within a web-based environment is very exciting to us,” noted Ellen C. Cooper, M.D., M.P.H., president and CEO at Summit. “We were looking for a solution that requires minimal IT support but offers a secure and collaborative environment in which to work with our clients. This solution provides a foundation for existing services as well as a launching point for new service offerings.”
ViewPoint, Octagon’s enterprise submission process management solution, improves visibility and facilitates the management of issues while unobtrusively collecting process metrics. ViewPoint’s hosted model provides a web-based foundation for communication and collaboration between Summit and its clients. Team members have the ability to participate in document and submission processes, evaluate planning assumptions and respond more quickly to project changes.
StartingPoint is an authoring template suite that includes over 200 submission document authoring templates. It will enable Summit to work efficiently at all levels required to support an electronic Common Technical Document (eCTD) submission. StartingPoint templates provide consistency and standardization across document authoring processes. “We advise our clients to incorporate authoring standards early in the process. By utilizing StartingPoint templates, we are building quality into drug development documents and facilitating electronic publishing tasks that are conducted later in the process,” noted Dr. Cooper.
“Summit understands the challenges inherent in document authoring and regulatory submissions,” noted Kirk Gallion, president, Octagon Research Solutions, Inc. “Minimizing rework and implementing standards with ViewPoint and StartingPoint will enrich the quality of Summit’s document and submission processes.”
For more information about Octagon’s technologies, including ViewPoint or StartingPoint, you can visit our website at www.octagonresearch.com or call us at 610-535-6500.
About Octagon Research Solutions, Inc.
Octagon is a pioneer and leading provider of breakthrough software and services to the life sciences industry. Octagon’s eCTD and CDISC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Berkhamsted, UK. Octagon’s EDC Operations are located in Mountain View, CA. For more information please visit www.octagonresearch.com .
About Summit Drug Development, LLC
Summit accelerates drug development by providing strategic focus and high quality preclinical, manufacturing, clinical and regulatory services to the pharmaceutical industry and public health sector. By aligning its expertise and resources with its clients, Summit embraces meaningful challenges in drug development with courage, creativity and integrity. For more information please visit www.summitdrug.com