Efficient and Compliance-Driven Reporting in Pharmacovigilance
The creation and management of regulatory-compliant reports is a key element of pharmacovigilance. We support you in automated and customized report generation to ensure full compliance with regulatory requirements and efficient processes.
Regulatory Reports and Custom Reporting
Our solutions cover a wide range of standardized and customized reports, including:
- Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) per ICH E2E guidelines.
- Development Safety Update Reports (DSURs) for clinical trials.
- Individual Case Safety Reports (ICSRs) in E2B(R3) format for electronic adverse event reporting.
- Signal Detection Reports for identifying potential safety risks.
- Compliance reports and management dashboards for monitoring KPIs and regulatory deadlines.
Modern Tools for Powerful Report Generation
We use powerful database and reporting tools to generate complex pharmacovigilance reports efficiently and in compliance with standards:
- Oracle Argus Safety for automated creation and management of ICSRs, PSURs, and PBRERs.
- Business Intelligence tools (BI), such as Oracle BI Publisher and Power BI for creating interactive dashboards and custom analyses.
- Axway B2BI for secure, standardized transmission of ICSRs to regulatory authorities.
- Database queries (SQL-based reports) for customized and detailed analyses tailored to your requirements.
Optimized Reporting with Data Warehouse & ETL
Efficient reporting requires a stable, centralized, and scalable data architecture. We design custom data warehouse solutions that provide a consolidated data base for pharmacovigilance reporting.
Our ETL processes (Extract, Transform, Load) allow for automated extraction of data from various systems, transformation into a unified format, and loading into a central reporting platform. This gives you:
- Faster access to cleaned, consolidated data for accurate analysis.
- Improved data quality and consistency through optimized transformation processes.
- Scalable infrastructure for managing large volumes of data across systems.
- Seamless integration with Oracle Argus Safety, Axway B2BI, and BI tools for optimized report generation.
Automation and Efficiency Gains
By integrating automation technologies, we reduce manual errors and improve reporting efficiency. Our solutions enable:
- Automated report generation and distribution based on scheduled timelines.
- Consistent data quality through standardized report formats and validation mechanisms.
- Rule-based alerts and escalation mechanisms to ensure deadlines and compliance requirements are met.
Training and Support for Reporting Systems
In addition to technical implementation, we offer tailored training on pharmacovigilance reporting tools and continuous support to ensure your team uses the systems efficiently and stays up to date.
With our expertise in Oracle Argus Safety, Axway B2BI, data warehousing, and modern ETL technologies, we ensure your pharmacovigilance reports are created efficiently, accurately, and in full compliance — for traceability and optimal regulatory readiness.