Wyeth Taps Octagon for eSubmissions Support
Wyeth Pharmaceuticals is expanding its esubmission program and capabilities working with Octagon Research Solutions, Octagon President Kirk Gallion told PIR Aug. 11.
Octagon just executed an agreement with Wyeth to begin using ViewPoint, Octagon’s enterprise submission process management solution, for managing complex, cross-functional processes in support of regulatory submissions, the company said in an Aug. 2 announcement.
Wyeth sees the value in taking a global approach to its esubmissions and avoiding reactive crisis management many other FDA-regulated firms fall prey to, Gallion said. “They share our vision for what electronic common technical document esubmissions can be,” he said.
ViewPoint will enable Wyeth’s Global Regulatory Affairs (GRA) to communicate within and across project teams and departments regarding project information. It will also provide visibility across business units on related projects and activities, track and manage a variety of regulatory projects and processes, and use ViewPoint’s Regulatory Dashboard to provide GRA real-time, daily views of information for all projects and processes.
At Wyeth, 22 regulatory business processes have been documented and configured within ViewPoint and more than 30 training sessions are to be administered by Octagon professionals over the coming weeks.
ViewPoint will also support GRA’s process for tracking and managing workload and resources. Using an accurate content plan with the associated task benchmarks, the GRA team can use ViewPoint’s Project Estimator tool to project resources and workload required to complete the project.
During the course of executing the project and processes, ViewPoint will be capturing data to enable GRA to produce and report on metrics as well as track regulatory and submission management activities. In addition, ViewPoint will provide reports that support GRA in getting project status information and compiling real-time metrics during the wrap-up of the submission project.
Wyeth is likely to leverage the system beyond regulatory compliance, Gallion said. But for now Octagon is in what he calls the “somewhat surprising” role of having to sometimes apply the brakes to new ideas for the technology. Instead, Octagon advocates getting one area fine-tuned before moving on to another part of the operation, he said.
Other FDA-regulated companies are taking notice, Gallion said. They’ve been receiving many inquires about their technology and esubs approach from regulated firms large and small in recent months, he added.
For more information, go to www.octagonresearch.com.