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ICSR (XML) validation tool

An automated validation tool before the ICSRs are finally sent to regulatory or other affiliates as a part of expedited/periodic submissions or for further quality analysis prior to submissions.

Safety management is turning global and submissions are becoming centralized using E2B specification guidance document. There is a need of automated validation 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 with respect to both R2 and R3 compliance.

PvEdge XML validator validates for

  • Mandatory fields (as per new R3 compliance) in XML
  • Character length allowed in XML nodes (Field wise character limitations)
  • Notification for un-allowed characters for rectifying the field values
  • EU and FDA region submissions, for differences w.r.t specific nodes
  • Rules as in E2B XML guidance document
  • Errors and warnings as per E2B specifications
  • Study cases as well as post-marketing cases/ICSRs
  • Final check at submission stage to rectify any pending error/warning messages

The hassle free ICSR (xml) validation check on PvEdge platform enhances maximum probability for positive acknowledgements for regulatory submissions for our clients and completely avoids the chances of getting negative acknowledgements.