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ICSR Submissions, Tracking and Compliance

ICSR submissions is extremely pivotal to assess periodically whether we have submitted as per the eligibility of submission rules in specific countries.

Why PvEdge?

  • PvEdge offers different report submission like CIOMS, MedWatch, VAERS, MDAERF, R2 and R3 XMLs etc.
  • PvEdge has pre-defined set submission rules as per requirement of regulatory authorities which are responsible for the accurate submissions
  • In PvEdge user can easily track the repetitive submissions as well as regional submission
  • PvEdge also has a provision of firing alerts according to the case submission priority
  • Accordingly, a compliance report can be generated with tracking delays with appropriate reasons
  • PvEdge is readily available for gateway connections for automated submissions of reports
  • We also offer provision to attach the acknowledgement file against the submission record
  • Manage case versions automatically in different regions when follow-up is received