BioTech
Adverse events platform built for FDA approval and long-term compliance
A pre-approval biopharma company needed a REMS portal to manage adverse events at FDA scale. We built it from scratch: secure, validated, and audit-ready.
The Business Challenge
A biopharma company navigating clinical trials and approaching FDA approval needed a centralized portal within their Risk Evaluation and Mitigation Strategy. The portal had to consolidate and triage adverse events and product complaints from multiple sources.
Their process was manual, error-prone, and exposed at the wrong moment in the regulatory timeline.
Our Approach
We built a responsive, multi-step submission framework that captured structured data across all devices and validated it before it ever reached the database. A centralized document collection system handled cloud storage, access controls, and secure on-demand retrieval. Automated reporting replaced the manual process.
Security was built into the hosting environment from day one, not layered on after the fact.
The Impact
The validated, SOC 2-compliant platform guided each adverse event from initial submission to final resolution, removing the uncontrolled handoffs that had created compliance risk. Error rates dropped. Audit readiness became the default, not a fire drill before each review.