Overview
Modernizing Adverse Event Reporting: Long-Term FAERS Support for the FDA
The U.S. Food and Drug Administration (FDA) relies on the FDA Adverse Event Reporting System (FAERS) to monitor the safety of marketed human drug and therapeutic biologic products. As the official system of record for both the Center for Drug Evaluation and Research (CDER) and the Center for Biologic Evaluation and Research (CBER), FAERS plays a critical role in post-marketing safety surveillance. Since 2010, Chickasaw Federal has supported every phase of the FAERS lifecycle, driving modernization efforts, maintaining system integrity, and ensuring regulatory compliance.
Challenge & Path Forward
Chickasaw Federal has provided strategic and technical support across all FAERS modules, including the implementation of FAERS II in AWS GovCloud. Our team collaborates closely with FDA stakeholders to translate evolving regulatory requirements into actionable IT processes and workflows. Leveraging expertise in security management, release management, regulatory COTS implementation, and Agile methodologies, we’ve led continuous improvements across system performance and user satisfaction, delivering secure, scalable, and compliant solutions for over a decade.
Results & Impact
Through expert project execution and a commitment to service excellence, Chickasaw Federal has elevated the capabilities of the FAERS platform. Our agile development team has successfully delivered high-impact enhancements, met demanding EPLC standards, and maintained best-in-class service levels. Over the last decade, several significant milestones have been accomplished. These include:
- Retirement of several legacy, enterprise level applications through successful partnerships with customers, vendors and stakeholders
- Implementation of multiple data-migrations through the development of data-mappings, data-sanitization and ingestion into new systems with minimal data-loss.
- Implementation of multiple Integrations for FDA centers through implementation of newly developed applications for efficiency in safety surveillance processes.
- Maintained long-term partnerships with multiple vendor teams to build subject matter expertise
- Managed full cradle-to-grave product implementations from inception to decommissioning phases.
- Implemented on-premise to AWS hosted infrastructure migrations
- Implemented ‘transactional’ intake systems for data with multiple integrations and customizations for COTS tools
- Implemented complex data-warehousing capabilities to comply with COTS limitations.
- Implemented data-mining capabilities to support US Post-market drug safety surveillance
- Full compliance with ever changing Federal regulations for drug safety.
- Integrated multiple, complex FDA use-cases, which were spread across multiple platforms into a single platform for post-market drugs, premarket drugs, product quality, cosmetics and biologic products.
- Adopted to multiple worldwide changes to data-standards for case submissions. (ICH E2b R2, E2B HL7 R3).
- 85% of tickets resolved within 3 days
- FAERS II system implemented in AWS GovCloud
- Supported full lifecycle for all FAERS modules since 2010
- Implemented over 450 successful production deployments
- 100+ bi-weekly scrums and sprints completed
- Expertise in security management, release management, and regulatory COTS implementation
- Continuous collaboration with FDA to align IT workflows with evolving regulatory standards
