Octagon's Innovative Answer to Industry's Changing Needs

Octagon's Submission Stewardship Program™ (SSP) delivers support capabilities to organizations that are making a commitment to move forward with electronic submissions in general or eCTD (electronic Common Technical Document) in particular. This strategic offering provides full submission capabilities on a long-term basis. The SSP extends the capabilities of the organization while simultaneously increasing potential capacity.

The SSP promotes a partnership model between sponsors and Octagon submission teams to facilitate the entire submission lifecycle. This partnership is the foundation that enables:

• Efficient exchange of documentation, study data, and eCTD metadata to support traditional eSub or eCTD deliverables
• The immediate extension of sponsor capabilities to support new submission formats
• The development of communication mechanisms and service level agreements that optimize the combined capabilities of both organizations
• A trusted, long-term relationship that is strengthened by Octagon's continued commitment to sustained domain knowledge, cross-functional eSub expertise and customer satisfaction

Octagon’s traditional Submission Stewardship Program enables clients to take advantage of a web interface for ViewPoint^®, Octagon’s enterprise submission process management solution, to manage and track issues. As part of a more fully integrated offering, customers may choose to deploy more robust functionality of ViewPoint to add submission management and compilation capabilities. This integrated sourcing model can be delivered in a hosted environment or through the traditional on-premise installation model. In both cases, clients realize the benefits of Octagon’s expertise while working within a controlled environment that support collaboration across the submission lifecycle.

For more Information about Octagon's Submission Stewardship Program

>> Download PDF of Regulatory Solutions Datasheet or Contact Octagon

Case Studies