Safety management is turning global and submissions are becoming centralized using E2B specification guidance document. There is a need of automated check before these ICSRs are finally sent to regulatory or other affiliates as a part of expedited/periodic submissions or for further quality analysis prior to submissions.
We are in an industry where compromise in quality of data can indeed be a costly yet irreparable affair. Safety data management and the procedure to comply with it necessitates a system in place; a robust system for reports submitted to different regulatory.
System allows validation of E2B XML files to ensure error-free XML submissions to regulatory
PvEdge XML validator validates for:
ESCALATING TO E2B (R3)…
We aim to ensure that safety data management for all product categories is eased with automation in its report submissions across different marketing regions. This would further assure adherence to the routinely implemented reporting guidelines
With the revised guidance already available on E2B (R3), we have planned and are soon to introduce PvEdge for E2B (R3) XML submissions. E2B (R3) dataset would eventually be required for successful XML submissions across the globe.
PvEdge is to implement very soon the R3 XML solution for global submissions.