NewswireToday - /newswire/ -
Wayne, PA, United States, 2007/09/11 - Octagon Research Solutions, Inc., today announced the successful completion of validation efforts for the ViewPoint FUSE, electronic data capture (EDC) platform, version 4.1.
Chairman and CEO, Jim Walker of Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical R&D in the life sciences industry, today announced the successful completion of validation efforts for the ViewPoint FUSE, electronic data capture (EDC) platform, version 4.1.
Luke Brennan, vice president, EDC Operations at Octagon described the comprehensive testing methodology, “We tested over 140 user requirements all of which the system passed successfully. Twenty-eight of these were related to 21 CFR Part 11 compliance including system and data security, audit trails and electronic signatures.”
The scope of this project was established by a two-phased approach. First, a risk-based approach was used to determine the requirements that must be met by the platform in order to demonstrate its compliance capabilities. Second, Octagon data management professionals applied their knowledge and practical expertise of industry practices to set forth a list of functionality considered integral to successful data management and EDC operations.
The testing activities covered a broad range of requirements including 21 CFR Part 11 compliance, management of sites, patients and case books, data entry and review processes, edit checks and manual and system-generated queries. Validation of the platform minimizes the validation activities required once a specific clinical study is designed and configured on the platform and will reduce the time to delivery for individual EDC studies.
Dave Evans, chief information officer at Octagon added, “ViewPoint FUSE is a critical component in Octagon’s “collection to submission” strategy. We applied the same stringent standards to our EDC platform that we use for all of our technology innovations. ViewPoint FUSE is a flexible solution that facilitates “connecting the dots” across the clinical data lifecycle. The validation of the platform represents a major milestone in our quest to manage the complete data lifecycle and uncover the deepest process efficiencies for our clients.”
About Octagon Research Solutions, Inc.
Octagon (octagonresearch.com) 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 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.