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Back[ Coventa ]Case Study

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Hub for Pharma Marketing

Promotional material reviewed against the rules it must satisfy. Hub reads marketing and prescriber documents including their images and charts, checks them against a versioned repository of compliance rules, and proposes reusable, human-approved content for drafting and localisation — under granular access control.

HUB // MATERIAL REVIEWAsset PM-2291 · compliance review
Hub MLR/Asset PM-2291 · compliance review
Sourcing verifiedLast sync 12s ago

Cardiva_HCP_Leave-Behind_v3.pdf · 4 pages · vision-extracted

Extracted · source-linked

Efficacy claim'42% reduction in events'p.1
Required contextvs placebo, 24 mo, n=4,812 — missing
Safety informationPresent · font below 8ptp.4
Fair balanceBenefits 3 : risks 1p.2
ReferenceHARMONY trial · NEJM 2025p.4
IndicationMatches label §1.1p.1

Checks

  • FDA 21 CFR 202.1
  • PhRMA Code §3
  • Regional: EU HCP
  • Approved content match
  • Signatory: Dr Ahmed

// Problem

The Problem

Therapeutic marketing material cannot ship until a medical signatory has confirmed it complies — with FDA regulation, with the PhRMA Code on Interactions, and with whatever additional guidance applies to that region and that therapy. That review is manual, it is a bottleneck by design, and it is performed on documents where the risk is often in the artwork: an efficacy chart with a truncated axis, a claim carried in an image rather than in body copy. Reviewers read the text carefully and the visuals quickly, which is the wrong way round.

  • Compliance risk frequently sits in charts and imagery, which text-based review tools cannot read.
  • The applicable rules span regulation, industry codes and region- and therapy-specific guidance held in different places.
  • Signatory review is the throughput limit on every launch and every localisation.
  • Approved content is not reusable in practice, so each new asset restarts the review cycle.

// Overview

Hub works on the whole document rather than its text layer. Large language vision models extract comprehensive context from marketing material and prescriber information — text, images, charts and graphs — so an efficacy graphic in a detail aid is reviewable on the same footing as a sentence. Against that extraction, a centralised, versioned repository of compliance rules is applied: industry regulation such as FDA requirements and the PhRMA Code on Interactions, alongside tailored guidance for specific regions and therapies, created or imported by the organisation. Discrepancies are surfaced to the user with suggestions for enhancement rather than a pass-or-fail verdict. For generation and localisation, a human-approved content ontology supplies material the system can recommend for reuse, with rephrasing options, so new documents start from language that has already cleared review. Privacy and security underpin the workflow, with granular access controls enforced across GDPR, FISMA, HIPAA and GxP obligations.

// AI System

Why AI

Vision is not a nice-to-have here; it is the requirement. A promotional claim expressed as a chart is legally identical to one expressed as a sentence, and a review system that reads only text is systematically blind to a whole category of risk. The second model task is matching extracted content against rules written as prose across several codes and jurisdictions — a comprehension problem, not a checklist. What the system explicitly does not do is approve: it surfaces discrepancies and proposes wording, and the medical signatory remains the person who signs.

// Specs

Specifications

EXTRACTION
Vision models over text, images, charts and graphs
RULES
Centralised, versioned repository — regulation, codes, local guidance
OUTPUT
Discrepancies surfaced with suggested enhancements
REUSE
Human-approved content ontology with rephrasing options
LOCALISATION
Compliant generation for geographic and therapeutic requirements
GOVERNANCE
Granular access control; GDPR, FISMA, HIPAA and GxP

// Features

Features

  1. 01Comprehensive context extracted from image-heavy advertisements and detail aids alike.
  2. 02Efficacy data in charts and graphs made reviewable, not skimmed.
  3. 03Versioned compliance rule library covering regulation, industry codes and local guidance.
  4. 04Discrepancies surfaced with enhancement suggestions rather than a binary verdict.
  5. 05Human-approved content recommended for reuse, with rephrasing options for new material.
  6. 06Localisation for specific geographic and therapeutic requirements, generated compliantly.

// Architecture

Architecture

REVIEW FLOW

Runtime · one item, left to right


  1. 01Marketing / Prescriber Document
  2. 02Vision Extraction
  3. 03Rule Matching + Discrepancy DetectionFDA RegulationPhRMA CodeRegional GuidanceApproved Content
  4. 04Suggested Enhancements
  5. 05Signatory Review
  6. 06Approved Asset

dashed = the inference step, where the system exercises judgment

System stack

Data in · decisions out

01

Sources

Assets and the rules they must meet

Marketing assetsPDF, video, web, printProduct label & PIFDA · PhRMA · regional guidanceApproved content libraryPrior review decisions

02

Ingestion

See the asset as a reviewer would

Vision extractionlayout, font size, placementClaim & reference parsingRule encodingversioned, jurisdiction-awareApproved content indexing

03

Ontology

Claim, rule, evidence

Asset · VersionClaim · ReferenceRule · JurisdictionDiscrepancySignatory decision

04AI

Intelligence

Match rules, find discrepancies, propose fixes

Rule matcherper claim, per jurisdictionDiscrepancy detectorcontext, balance, legibilityEnhancement proposerfrom approved phrasingPrior-decision recallEval suitereviewer agreement

05Human

Human control

The medical signatory approves

Signatory approvalRole-based accessAgency return loopImmutable decision record

06

Actions

Written back

Approved asset & job codeAgency feedbackRegulatory archive

Observability

Every model call traced; evals run on real cases, not anecdotes.

Governance

Entitlements enforced at retrieval; rules versioned by the organisation.

Write-back

Systems of record are written only through the approval gate.

The system surfaces and proposes; the medical signatory approves. Access is enforced per role throughout.

// Impact

Impact

Text + visual
Review coverage, against text-only toolingdesign intent
Versioned
Rule repository, against distributed guidancedesign intent

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// End of case studyHub for Pharma Marketing