OCTAGON RESEARCH SOLUTIONS INC., UNVEILS VIEWPOINT® 3.6 AND NEWLY DESIGNED eCTD SUITE 2.0
Wayne, PA. -June 20, 2006 – Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical R&D to the life sciences industry, today unveiled ViewPoint® 3.6, the latest edition of the industry’s first comprehensive Enterprise Submission Process Management Solution, for managing complex, cross-functional processes in support of regulatory submissions. In addition, the company also announced availability of the Octagon eCTD Suite, which includes Octagon’s eCTD Viewer and eCTD Validator.
Octagon’s award winning ViewPoint® solution streamlines the submission process for Pharmaceutical/Biotech organizations by providing visibility into the planning and management of the drug submission processes while allowing users to track, manage and compile any type of regulatory application.
ViewPoint 3.6 Resource Estimator, Reviewer and Regulatory Dashboard have been enhanced to provide unprecedented workflow estimation, collaboration and project tracking across the submission lifecycle.
“When utilizing the ViewPoint Regulatory Dashboard, submission managers have real-time visibility into the status of deliverables, issues, resources and milestones within submission projects,” stated Kirk Gallion, Octagon’s president, “The new web-based ViewPoint Reviewer provides content contributors with the ability to view their document in the context of a submission, this is the next generation tool that the industry needs, here today.”
As the industry continues to move toward global standards for regulatory submissions, companies must be ready for the intricacies of implementing the eCTD. Octagon’s innovative eCTD suite offers comprehensive viewing and validation capabilities, limiting the risk of missing a submission date or filing an incomplete or noncompliant eCTD submission.
Octagon’s eCTD Suite 2.0 includes the eCTD Validator, which allows users to confirm that their submissions are meeting the expectations set forth within ICH and regional specifications, guidance and industry best practices. Octagon’s eCTD Viewer provides practical viewing functionality that supports the entire eCTD submission lifecycle. Octagon’s eCTD Viewer also facilitates searches across instances and displays leaf lifecycles including leaves in related dossiers.
“Yesterday’s paper-based technologies and processes cannot deliver the efficiencies and intelligence that Pharmaceutical and Biotech companies need to make effective decisions about their submissions and execute them in real-time,” says Jim Walker, Octagon’s CEO and Chairman. “By providing solutions that offer greater clarity and control over their operations and complete support for evolving submission standards such as eCTD, we’ve transformed the complex submission process into a science.”
ViewPoint 3.6 and the Octagon eCTD Suite 2.0 will be available for demonstration at the 42nd Annual DIA (Drug Information Association) Meeting on June 18-22nd at the Philadelphia Convention Center booth number 1809.
About Octagon Research Solutions, Inc.
Octagon is a pioneer and 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 integrated solutions. Octagon is headquartered in Wayne, PA, with offices in Boston, MA, Costa Mesa, CA, and European headquarters in Amersham, UK. For more information please visit www.octagonresearch.com.
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