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. The group has consistently met submission timelines and has never received a "refuse to file" from regulatory authorities.
A regulatory submission is a mission critical process and the submission date is often tied to partner or milestone payments, management bonuses and other organizational incentives. An original application represents the culmination of years of research and therefore is high exposure within an organization and the stakeholder community.
Most submissions consist of thousands of documents and data files in numerous different formats that require different processing paths to make them compliant. At any given time the Regulatory group may be managing over 30 different submission projects (and their lifecycles). Adding to the complexity, as eCTD submission projects have become more frequent, additional meta data for each individual component of the submission also requires tracking and management throughout the submission lifecycle.
Sponsors who choose to outsource submission production and compilation place a great deal of trust in their submission partners to provide the highest quality deliverables. Octagon developed process management requirements based on the need to respond to sponsor inquiries immediately and manage resources, tasks and issues in the most efficient way possible. The company needed to ensure accountability for every piece of information received from a sponsor. They also needed more visibility into the complex submission process, including resource availability, project statuses and the management and tracking of issues throughout the project.
In addition to process management requirements, the Regulatory function also needed the capability to compile, view and validate submissions in electronic Common Technical Document (eCTD) format.
The development and deployment of ViewPoint was focused on providing visibility into the process in terms of project pipelines, resources, statuses and issue resolution while also ensuring that quality levels are maintained throughout the submission process. The deployment of eCTD compilation, viewing and validation capabilities was also important to support increasing number of eCTD submissions and their maintenance submission lifecycle.
Viewpoint, Octagon's enterprise submission process management solution, was deployed as a means to control a complex process while also providing accountability for each project deliverable. The standard desktop configuration was deployed to all Regulatory personnel while sponsor contacts were provided access to their projects through the ViewPoint Reviewer web interface. Octagon processes were mapped into ViewPoint workflows according to documented standard operating procedures and issue workflows were created with built-in escalation procedures. Thirteen relevant SOPs and 71 guidance documents were also linked within the application so that users could reference them at any time during the process. Project specific publishing standards such as linking strategies were also incorporated as projects dictated. Functional training was conducted to ensure that users understood the process and the technology fueling it.
ViewPoint's eCTD compilation functionality was deployed to Regulatory users to support the compilation of final eCTD submission deliverables in compliant folder structures with appropriate "xml backbone" files that support navigation through the structure.
Octagon's eCTD Viewer and eCTD Validator were deployed to address requirements for key team members to validate a submission and to provide viewing capability across the functional area.
Regulatory Operations Managers use ViewPoint project dashboard views to ensure project milestones are met and to estimate current resource allocation and future recruiting requirements. Current resources are automatically assigned to project tasks based on individual competencies as well as availability.
Project Coordinators and publishers utilize ViewPoint to manage specific project tasks and to communicate with sponsors regarding issues and their resolution. They also use ViewPoint's eCTD Compiler to automatically generate eCTD compliant deliverables.
Regulatory Affairs personnel utilize the standard desktop configuration to review and quality check submission components and to identify issues in real-time.
Sponsor companies access ViewPoint through the ViewPoint Reviewer module, which facilitates content review and issue communication and resolution.
Role-based access to submission content and processes enables the team to focus on the task at hand while management monitors the bigger pipeline picture. In this manner, strategic, operational and tactical process information is presented throughout the submission lifecycle, offering process transparency and control.
ViewPoint is currently deployed in the production environment at Octagon and provides efficiency, visibility and accountability into all aspects of the submission process. It has facilitated the institutionalization of best practices and allows managers to proactively adjust resourcing strategies as project pipelines dictate. Standardized workflows, real-time metrics collection and benchmarks facilitate process improvement, analysis and follow up activities. Issues are tracked and managed throughout the entire lifecycle and real-time communication with sponsors assists in rapid resolution. A submission date has never been missed because managers have the ability to more effectively manage skilled resources.
The value of the solution continues to be realized as new projects are initiated and ongoing projects continue to require resources for maintenance activities. Octagon not only offers outsourcing of original eCTD applications but also the lifecycle maintenance of those applications. This requires detailed orchestration of all the moving parts of the submission components as they travel through the lifecycle. ViewPoint provides visibility into the status of the components, the resources working on the components and any looming deadlines that may be impacted by issues. Tight submission timelines, strained resources and unplanned events continue to be the status quo for the regulatory submission industry. ViewPoint helps Octagon maintain their sponsors' trust by controlling the process into submission.
Contact Octagon to learn more about how your organization can benefit from process visibility and control and eCTD capabilities offered by Octagon's Technology Innovations Team.
