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![](/download/attachments/327878/%2323407%20PHUSE%20Working%20Group%20Banners%20Aug%202020%20Web%20Size%20v3_Data%20Visualisation.jpg?version=1&modificationDate=1604049692376&api=v2)
While interoperability and standardisation have been goals of the Pharmaceutical Data Science Industry for years, much of the work 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 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 compliant eCTD package will be discussed
Project Lead: