While interoperability and standardisation have been goals of the Pharmaceutical Data Science
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Industry for years, much of the work
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to create and validate a submission package is done manually or with proprietary software. Integrating tabular study data, study metadata, STF data, and visualisations are low-hanging fruit for a collaborative industry solution. Open-source tools have matured in their reliability and flexibility. This
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project will explore their emerging use in regulatory submissions. The topics of tools that assist in creating a submission package, the cost of these tools, and the necessary controls and validation needed to create and maintain a
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