Vitrana’s 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.

• Pre-defined extended E2B mapping for KOREA, RUSSIA, TAIWAN, PMDA, NMPA, EMA, FDA PMSR, eVAERS, eMDR and EUMIR. 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
• Comprehensive OOB Validation Toolkit

The TransformPV solution has been a game-changer for us. With its advanced capabilities, we have been able to streamline our processes and improve efficiency while ensuring compliance with regulatory requirements in Korea, China, and other countries. The solution has saved us both time and money by eliminating the need for expensive upgrades to our existing systems. I highly recommend the TransformPV solution to any organization looking for a comprehensive and cost-effective compliance solution for meeting regional reporting requirements.

The IT manager
Tier 1 Pharma Organization