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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.
Cardiva_HCP_Leave-Behind_v3.pdf · 4 pages · vision-extracted
Extracted · source-linked
| Efficacy claim | '42% reduction in events' | p.1 |
| Required context | vs placebo, 24 mo, n=4,812 — missing | — |
| Safety information | Present · font below 8pt | p.4 |
| Fair balance | Benefits 3 : risks 1 | p.2 |
| Reference | HARMONY trial · NEJM 2025 | p.4 |
| Indication | Matches label §1.1 | p.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
- 01Comprehensive context extracted from image-heavy advertisements and detail aids alike.
- 02Efficacy data in charts and graphs made reviewable, not skimmed.
- 03Versioned compliance rule library covering regulation, industry codes and local guidance.
- 04Discrepancies surfaced with enhancement suggestions rather than a binary verdict.
- 05Human-approved content recommended for reuse, with rephrasing options for new material.
- 06Localisation for specific geographic and therapeutic requirements, generated compliantly.
// Architecture
Architecture
REVIEW FLOW
Runtime · one item, left to right
- 01Marketing / Prescriber Document
- 02Vision Extraction
- 03Rule Matching + Discrepancy DetectionFDA RegulationPhRMA CodeRegional GuidanceApproved Content
- 04Suggested Enhancements
- 05Signatory Review
- 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
02
Ingestion
See the asset as a reviewer would
03
Ontology
Claim, rule, evidence
04AI
Intelligence
Match rules, find discrepancies, propose fixes
05Human
Human control
The medical signatory approves
06
Actions
Written back
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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