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Enterprise Submission Process Management
Process Management entails managing the resources, tasks, content and issues associated with a particular process. Enterprise Submission Process Management involves managing all of those components of the Clinical R&D cycle, with a goal of getting an innovative product to market. Directly or indirectly, most members of the R&D organization contribute in some way to the creation and submission of a regulatory application. Years of research culminate in the compilation and submission of documents and data to global health authorities. Throughout this multi-year process, many cross-functional resources are used to research, analyze, author, review and compile the large quantity of data to support a marketing application. Many interrelated sub-processes are initiated, executed and completed. Often issues arise that may affect the final submission contents or the expected delivery date. These issues are often traced back to lack of process visibility, process design flaws or training concerns.
Competitive organizations are beginning to look at the submission value chain and define it in the much broader context of the enterprise. They are also taking a closer look at current processes and analyzing gaps or areas where rework and redundancy occur between functional areas. By doing so, these organizations are taking a process-centric approach to performance optimization. This approach will lead to recurring efficiencies
Many of the benefits of enterprise submission process management are predicated on the design and alignment of quality processes that span cross-functional barriers. These processes vary in complexity and address everything from data management to submission compilation. As organizations move forward and gain efficiencies as a result of good enterprise submission process management, new technologies will emerge to support new submission deliverables and new ways of doing business.
The umbrella term “enterprise submission process management” covers a wide spectrum of activities, skill sets, standards, resources and technologies. Many submission-related best practices or methodologies may be considered components of good submission process management. Some target very specific activities while others address larger cross-functional initiatives. Whether you are wrestling with new technology implementations, training resources on new submission deliverables or simply trying to work more efficiently with an outsourcing partner, being good at enterprise submission process management will allow your organization to reap numerous benefits including increased efficiency, decreased costs and reduced risk.
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