Autonomous Claims Validation System for Global Pharma Operations

Summary

A Swiss multinational healthcare and biotechnology company partnered with Aria Intelligent Solutions to design HarmonIQ Claims OS — an agent-led autonomous validation system that extracts, scores, remediates and publishes pharmaceutical marketing claims against the proprietary 6C Framework. Following a successful Proof-of-Concept that was approved by the business, the platform is now being productionised at enterprise scale to replace serial, multi-week Medical-Legal-Regulatory (MLR) review cycles with continuous autonomous validation — governed by embedded compliance rules, regulatory knowledge bases and a self-improving memory layer. Every validated claim is auditable, citation-backed, and built to be deployment-ready across global markets.

Impact At A Glance

POC Approved

8 Agents

Forensic Scoring Coverage

The Challenge

The company’s medical affairs and global marketing functions were operating on manual, sequential MLR review cycles — each pharmaceutical claim required serial sign-off across regulatory, medical, legal and brand stakeholders, slowing time-to-market for HCP campaigns, congress materials and patient assets. With an expanding asset portfolio and divergent compliance regimes across multiple global markets, the existing process struggled to scale, detect duplicates, or maintain a single canonical source of truth for approved claims.

The Claims Operation System programme was initiated with three clear objectives:

Validate whether an agent-led system could autonomously score pharmaceutical claims against a forensic, evidence-anchored compliance framework
Ensure every output was grounded in Roche’s regulatory evidence base, market-specific rules and Must-Not-Say constraints
Establish a scalable foundation for portfolio-wide, continuous claims validation, remediation and publication

The Solution: Multi-agent Validation Architecture

The system is built on a coordinated 8-agent architecture orchestrated by Claude on AWS Bedrock. An intelligent orchestration layer governs a continuous agentic cycle — extracting claims from source documents, executing forensic 6C scoring through a multi-turn tool-use loop, and remediating before publication into the validated claims library. Five core capabilities underpin the platform:

Agentic 6C Validation Loop

Multi-turn Converse API loop where Claude autonomously selects from 10 purpose-built tools, scores each of the 6C dimensions — Clarity, Connectivity, Context, Consistency, Completeness, Compliance — and iterates until a complete forensic finding is produced.

8-Agent Specialist Network

Dedicated agent personas — HarvestIQ, ValidatorIQ, ComplianceGuard, PersonaMapper, ChannelArchitect, MemoryAgent, ExtractIQ — each with distinct expertise across source verification, regulatory rules, audience mapping and pattern learning.

Regulatory Knowledge Bases

AWS Bedrock Knowledge Base plus structured drug repositories codify CSRs, prescribing information, market-specific compliance rules (VVPM, Must-Not-Say) and Brand Claims Matrices — anchoring every score in verified evidence rather than model priors.

Memory & Learning System

Persistent pattern extraction from human corrections — every fix surfaces a reusable pattern through a Pending Review → Active workflow, so the platform compounds institutional expertise over time.

Continuous Document Pipeline

Google Drive → S3 sync, autonomous claim extraction, fuzzy de-duplication and a side-by-side correction editor publish validated claims to a governed output database with full JSON / CSV export.

Unlike traditional MLR review, every 6C dimension finding cites the underlying source evidence — making outputs auditable, defensible and immediately deployable across global markets.

Results & Business Impact

POC Validated, Approved by the Business

The POC demonstrated that an agent-led system could autonomously extract claims and surface evidence-cited 6C scores on a rolling basis — replacing multi-month serial MLR cycles with on-demand validation. Forensic findings were tested against the manual MLR baseline and signed off by the company stakeholders as the basis for production roll-out.

Trust by Design

Every dimension finding is grounded in cited source documents and codified market compliance rules — not statistical confidence. Forensic, adversarial scoring eliminates the false confidence that typically undermines AI in regulated, high-stakes environments — the foundation on which enterprise scaling has now been authorised.

Productionising at Enterprise Scale

With POC sign-off secured, the system is now being hardened and rolled out across the wider asset portfolio — extending multi-market compliance coverage, encoding full persona taxonomies and channel architectures, and embedding the validated claims pipeline into the company’s day-to-day MLR workflow to unlock material claims-cycle cost reduction.

From Poc To Enterprise: The Journey

Phase 1

POC Design

Drug portfolio scoped
6C framework codified
Regulatory KB ingested

Phase 2

Agent Deployment

8-agent network activated
10 Bedrock tools wired in
Memory & learning live

Phase 3

POC Approved

Scored vs MLR baseline
Citations integrity confirmed
Business sign-off secured

Phase 4

Productionising (In Flight)

Hardening for production
Multi-market roll-out underway
Embedding into MLR workflow

With the POC approved by the business, the programme is now in active enterprise productionisation — translating proven technical capability into regulatory trust, governance maturity and material cost reduction across the company’s global pharmaceutical claims operations.