ViewPoint^® Case Studies

Small/Midsize Company Deployment Scenarios

• Deployment Scenario: eCTD Capabilities and Submission Process Management
  Octagon's Regulatory Affairs and Operations personnel publish, quality check and compile electronic submission documents and data for submission to worldwide regulatory authorities on behalf of our sponsors. The Regulatory function consists of over 60 Regulatory Operations professionals (Managers, Project Coordinators and Publishers) and 10 Regulatory Affairs professionals. More...
  

Large Company Deployment Scenarios

• Deployment Scenario: Regulatory Submission Planning and Management
  A large pharmaceutical company with a significant submission pipeline required the ability to orchestrate all of the activities and resources associated with the submission process in order to maximize process efficiencies. The research and development organization operated across 8 sites in the US and Europe.
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• Deployment Scenario: Issue Lifecycle Management for Submission Components
  A large, global pharmaceutical company had over 100 submission resources globally with approximately 50 resources focusing on coordination and ensuring submission components are submission-ready for regulatory processing. Several non-scalable, non-integrated point solution technologies were being used to support the submission process. More...
  
  
• Deployment Scenario: ViewPoint® for Data Lifecycle Standardization
  A large pharmaceutical company struggled with standardization of data terminology and supporting processes across multiple global sites. The company instituted a data lifecycle standardization initiative to provide global access, deployment and visibility for all clinical data standards. More...