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Octagon announces ViewPoint FUSE 4.2, its Electronic Data Capture solution, which produces submission-compliant output
Octagon Technology platform connects data collection to submission
(WAYNE, PA, June 23, 2008) - CEO & Chairman Jim Walker of Octagon Research Solutions, Inc., a pioneer and leading provider of breakthrough software and services to the life sciences industry, today announced the availability of the industry’s first practical solutions that connect output from data collection directly into the regulatory submission process. ViewPoint® FUSE Electronic Data Capture (EDC) system and ViewPoint®, Octagon’s enterprise process management solution are the foundation for this boundary-bursting approach to electronic R&D processes.
This week at the DIA Annual Meeting, Octagon is previewing ViewPoint FUSE 4.2, Octagon’s Electronic Data Capture solution, which produces submission-compliant output including bookmarked and hyperlinked PDF (Portable Document Format) case report forms as well as data that is compliant with the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM). Users of the system have the option to generate case report forms with navigation based on either FDA CDER or CBER specifications for electronic submissions.
Once data is collected and begins to travel toward analysis and review, ViewPoint controls multiple processes. A particular challenge in industry is the creation of shell documents for the tables, listings and figures that support a clinical study report. These templated documents are used by statisticians as a communication tool for the study team to facilitate data collection and programming. These mock shell tables listings and figures are living documents that are time consuming to create, difficult to maintain because of frequent updates and are continually accessed by multiple team members. Octagon has designed a ViewPoint process that automates the creation and maintenance of these shell documents. ViewPoint manages the SDTM domain standards, meta data and template information used in the creation of these shells. Once the appropriate information is entered shell table listings are generated for programmers to review. The resulting shell documents are easily updated and accessible to team members through the ViewPoint platform. In addition, once the final tables, listings and figures are generated, ViewPoint generates a comprehensive tables, listings and figures document with a hyperlinked table of contents and title page. These documents are stored in the Study area for reference and reuse in creating shells for other studies and supporting development of additional submission deliverables.
Kirk Gallion, president of Octagon Research Solutions noted, “The concept of “on-demand” generation of templated content can also be applied to other areas of the submission process where meta data, content and templates can be automatically merged to create newly aggregated and consistently formatted content. Manufacturing and quality data and certain safety documentation are good candidates for this type of automated process.”
Jim Walker, chairman and CEO, added, “The technology and process connections are very strong. As we develop new ways to automate the data, document and submission lifecycles, we are shortening the distance from collection to submission. Because of this broader perspective, we have the opportunity to make a much more significant impact on clinical R&D than any existing technology vendor. We will continue to focus our development efforts on the ViewPoint FUSE EDC platform and the ViewPoint enterprise process management platform as they are foundational technologies for management and delivery of our solutions.”
To see a preview of ViewPoint Quantum or ViewPoint FUSE, visit Octagon’s exhibit booth at the DIA Annual Meeting (Booth #630), contact Octagon at 610.535.6500 or visit our website at www.octagonresearch.com.
About Octagon Research Solutions, Inc.