PHUSE US CSS 2020 PP08 : Taking full advantage of the SEND data potential
Jointly published by Roche and PointCross Life Sciences
Establishing robust processes for SEND data package preparation for regulatory submissions to FDA present great challenges for the Industry, but created the opportunity of having digitized, machine readable, highly standardized study data for search, exploration, comparison across studies and analysis. In this poster, we present our current experiences in utilizing SEND data for three main business cases:
1) Improving efficiency of study monitoring with access to “real time” data for ongoing studies. For this purpose, we developed a fully automated workflow covering data acquisition, transfer and database upload.
2) Simultaneous review of [audited] draft reports with accompanying complete SEND data packages. Efficient report review and reconciliation while verifying the fitness, consistency, completeness and accuracy of the SEND data.
3) Cross-study analysis to facilitate data interpretation and gaining insights across individual studies or submission package(s). The three use cases are supported by a single User Interface dubbed RoDEo