E2b conversion

TransformPV™ will enable existing safety applications to transmit and receive E2B(R3) ICSR XML’s and R3 ACK files. The E2B(R3) adapter allows organizations to transform E2B(R2) files into E2B(R3) files and vice-versa. 

TransformPV™ is developed and maintained by Vitrana Inc. Through a partnership, Insife and Vitrana  deploy E2b conversion solutions in collaboration. The partnership combines the proximity and deep understanding of clients and industry with a large selection of market-proven solutions and cost-effective project delivery

Architectural overview
  • Ready to use built in EMA BFC support

  • Pre-defined extended E2B mapping for EMA, VAERS and EMDR. The ready to use extended R2 mapping reduces implementation and customization effort and time

  • R2-R3 tag by tag view functionality wherein it lines up both the E2B(R2) and E2B(R3), on single screen based on the R2-R3 mapping provided by the ICH

  • De-mystifies E2B(R3) to business users who are well conversant and proficient in R2 tags

  • Profile based approach for configuration to manage the regional requirements allows targeted implementation based on availability of regional guidance and reduces validation impact as each regional guidance is in individual agency silos within the TransformPV

  • Track ICSR and ACK using the TransformPV Worklist

  • OOB Integration with Safety Systems

  • Inbuilt Audit Log and Error Log functionality



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