The answer lies in Signal Detection. AI has long been used to predict adverse drug reactions during drug discovery, so it makes sense that the same technology can help detect adverse events with patients. However, this isn’t just about adverse event reporting. It’s about transforming compliance from a reactive process to a proactive real-time capability.

Industry Changes:

Each year, the FDA receives over two million adverse event and medication error reports associated with the use of drugs and biologic products. These reports feed the FDA Adverse Event Reporting System (FAERS), which plays a critical role in monitoring product safety. However, the FDA acknowledges inherent limitations, such as reports being incomplete, inaccurate, untimely, and unverified.
To address these challenges, the FDA is modernizing its approach:

• Harmonized Standards: Since early 2024, the FDA has adopted broader use of electronic submissions for expedited and non-expedited reports using the E2B(R3) standard. Submitters must implement this by April 1, 2026.
• Form Updates: Changes to Forms FDA 3500, FDA 3500A, and FDA 3500B aim to clarify reporting and align with current regulations.
• Faster Data Access: In August 2025, the FDA began publishing adverse event reports daily through FAERS, replacing quarterly updates. The FDA Commissioner emphasized the goal in this quote:

"People who navigate the government’s clunky adverse event reporting website should not have to wait months for that information to become public. We’re closing that waiting period and will continue to streamline the process from start to finish."

FDA Commissioner Marty Makary, MD, MPH

This shift signals a new era of real-time safety surveillance, and industry must keep pace.

The New Challenge:

Compliance has traditionally relied on after-the-fact spot checks and manual audits. While effective, they are manual processes that take significant time. With evolving FDA expectations, the challenge is clear: how do we move compliance from retrospective to real-time while simultaneously keeping up with changing standards?

The Valeris Use Case:

Valeris’s AI-driven quality solution is designed to do exactly that. By embedding signal detection into every interaction, it enables:

• Real-time Compliance Monitoring: the platform flags alerts instantly in a single inbox, allowing agents to accept, decline, or escalate issues without delay.
• Live AI Assistance: during conversations, AI provides guidance to help agents during the call, reducing the potential for missed adverse events.
• Automated QA at Scale: every call is scored automatically, detecting deviations from policies in real time and flagging potential adverse events. This ensures adherence to regulations and accelerates continuous improvement.
• Hybrid Approach: Valeris combines AI-driven automation with human oversight to prevent risks associated with fully autonomous systems.

This isn’t just about efficiency; it’s about building compliance into the fabric of operations.

Anticipated Impact:

The benefits of real-time signal detection are transformative:

• Immediate Risk Identification: issues are flagged during the interaction.
• Operational Efficiency: automated QA reduces manual workload and leaves more time for patient calls.
• Regulatory Confidence: continuous monitoring ensures readiness for evolving standards

Why Signal Detection Matters

Signal detection is more than a technical feature – it is a compliance strategy. Just as the FDA has adopted daily reporting and harmonized standards, organizations must adopt tools that enable continuous monitoring and immediate response. AI-driven signal detection elevates compliance from a daily task to an embedded, dynamic process that evolves with regulatory expectations.