E2B ICSR Exchange Flow
Streamline safety reporting with secure, compliant E2B data exchange.
Our E2B Configuration Capabilities
Streamlined Electronic ICSR Submission. Globally Compliant. Seamlessly Integrated.
ICH E2B(R2) & E2B(R3) Support
Full setup and validation for both E2B versions, including hybrid environments.
XML Message Mapping & Validation
Precise mapping of safety database fields to ICH-compliant XML, validated against global and regional schemas.
Gateway Configuration
Setup of secure transmission gateways (AS2, WebTrader, EV Gateway) with encryption and tracking.
Sender & Receiver Profile Management
Configuration for EudraVigilance OrgID, FDA ESG registration, and other authority-specific profiles.
MedDRA & WHO Drug Dictionary Integration
Automated import, mapping, and version control of key pharmacovigilance dictionaries.
Regulatory & Business Rule Setup
Apply regional validation rules to reduce rejections and ensure successful submissions.
ICSR Lifecycle Management
Support for all reporting types: initial, follow-up, amendment, and nullification.
Audit Trails & GxP Compliance
Complete traceability of all actions during the ICSR submission process.
Testing & Qualification
Pre-launch testing with regulatory agencies (e.g., EMA XCOMP, FDA ESG).