Submission Stewardship™ Case Studies

Client Engagement:
StartingPoint^®, Process Consulting, Submission Outsourcing, Submission Stewardship Program™

Scenario:
The Regulatory Department of a small pharmaceutical company consisted of three people. Their company was very forward-thinking in their preparation for eCTD. As a first step, they purchased, installed and implemented StartingPoint^®. As the company grew, they deployed electronic document specialists to each of the contributing functional areas to facilitate the authoring process and to ensure creation of electronic submission-ready documents. Octagon assisted the client in training the broader authoring community and developing standards of practice for file naming conventions and folder structures in lieu of a formal document management system. As a result, the company was able to successfully produce high quality eSubmission-ready documents. Octagon extended the team's capabilities by also providing fully outsourced submission publishing and compilation through the Submission Stewardship Program™. Octagon compiled the original application and continues to publish and compile all follow up maintenance submissions.

Value Statement: Octagon provided technologies supported by strong process expertise to ensure the client was able to transition smoothly and quickly. Octagon's integrated submission outsourcing teams extended the client's internal capabilities to support the eCTD format.