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
