E2B Bridge

E2B BRIDGE is Prudentia’s Backword and Forward Conversion (BFC) Tool offered as a cost effective solution for companies with safety database unable to import E2B (R3) to E2B (R2) and generates a user friendly E2B (R3) Readable Report including a R3-R2 comparison report highlighting R3 unique elements and R2 truncated data elements. BRIDGE also extracts embedded document (e.g., literature article, lab records) from E2B (R3) files.

BRIDGE is offered in two edition – Portal and Integrated

Features

Portal Integrated
User friendly viewer and PDF for R3 data . .
User friendly viewer and PDF for R3-R2 comparison . .
Converted R2 xml file available for download . .
Download document set as a single zip file . .
Validation of E2B R3 file against schema definition . .
Multiple conversion profile handling (e.g, EMA, FDA, custom) . .
Smart E2B+ mapping to handle unique E2B (R3) elements . .
Multiple E2B (R3) file upload to conversion .
Tracking & Monitoring of R3 conversions .
Automatic Import of R2 files to Create case in safety database .
Automatic attachment of supplement R3 Documents to case .
Hosted by Prudentia .
On premise installation . .

BRIDGE FUNCTIONS

Start

Conversion

View

R3 reports (optional)

View

embedded documents (optional)

Download

converted file and reports

Finish