E2B Reporting – Efficient and Compliance-Driven Adverse Event Reporting
We support you throughout the entire E2B reporting process to ensure secure, automated, and compliant transmission of adverse drug reactions (ADR) to health authorities and partner companies. Our services include:
- Implementation of reporting rules and destinations according to the regulatory requirements of different countries and authorities (FDA, EMA, PMDA, etc.).
- Profile maintenance and updates (R2/R3) to ensure continued compliance with ICH E2B guidelines.
- Seamless gateway communication with regulatory agencies and integration with global safety databases via Axway B2BI for secure and efficient data transfer.
Regulatory Compliance & GxP-Conformant Validation
All processes are GxP-compliant and validated to meet the highest standards, including FDA 21 CFR Part 11, EU-GMP Annex 11, and ICH E2B(R3). We take care of:
- Creation of all GxP-relevant documents including User Requirement Specifications (URS), Functional Specifications (FS), Validation Master Plans (VMP), and test protocols (IQ/OQ/PQ).
- Development and maintenance of Standard Operating Procedures (SOPs) for the E2B workflow to ensure sustained regulatory compliance.
- Regular audit readiness checks to ensure your system always meets the latest regulatory standards.
Automation & Efficiency Improvement
We focus on intelligent automation solutions to reduce the manual effort involved in capturing, processing, and transmitting E2B reports. With Oracle Argus Safety, we offer a powerful platform for automated case processing, electronic submissions, and rule-based workflows—maximizing both efficiency and compliance.
Training & Ongoing Support
In addition to technical implementation, we ensure your team works effectively with the systems. We offer:
- Targeted training for Oracle Argus Safety & Axway B2BI to ensure secure and efficient use.
- Ongoing support and system updates to continually align your E2B processes with new regulatory requirements.
With our expertise in Oracle Argus Safety, Axway B2BI, and regulatory frameworks, we deliver a secure, efficient, and future-proof E2B reporting solution.