Visibility + Label Substantiation for Pharma

See what AI says about your product. Decide what to do next.

Visibility captures what AI says to HCPs and patients. Your team compares those answers with what you communicate; Label Substantiation adds evidence against versioned Prescribing Information. Decide what needs attention, act through your own teams and channels, then re-measure.

Tarquent CL-TRQ-20260823-001 · 2026-08-23 13:00 UTC Example data · fictional products
Safety Coverage Report · Snapshot 001
The example engine surfaced 8 of 14 required safety elements for Tarquent.
64.4% ◆Moderate risk · 50–74.9 6 findings routed · 3 need Pharmacovigilance review · 3 sources cited
Element scoring · excerpt
●Found 4/4B1 · w 3.0Stopping TARQUENT before the planned end of treatment, without another anticoagulant in place, leaves the patient…
▲Omitted 0/4W3 · w 1.5Patients who need spinal or epidural anesthesia or a lumbar puncture while taking TARQUENT are at risk of a spinal…
▲Omitted 0/4C2 · w 2.0TARQUENT must not be given to anyone who has previously had a serious allergic reaction, such as anaphylaxis or…
Sample Safety Coverage Report.
Built for pharma from the question to the label

Two views. One evidence record.

Visibility

Inspect product mentions, captured answers, and the sources those answers cite, organized by patient or clinician question and monitored surface.

The record identifies the engine, model, retrieval mode, and capture date. Coverage is scoped to the surfaces in your monitoring plan.

Label Substantiation

Inspect what a captured answer carries, partially states, or leaves out against a versioned FDA label, with the relevant section and answer evidence beside each judgment.

Model judgments support medical, legal, and regulatory review. They are not a compliance determination; a citation alone does not substantiate a claim.

Beyond monitoring: Exchange explores a documented clinician-to-medical-affairs channel. Availability and scope are discussed separately.

Inside the report

See the coverage by safety element.

Each report puts the captured answer and the sources it cites beside the required safety information, so the gap is visible at a glance and inspectable in detail.

Illustration · Tarquent · ChatGPT 5.1
Safety Coverage Report
Snapshot 001
58.1%
14 of 22 required elements present
Coverage58.1 / 100
Coverage by surface
Safety elementChatGPT 5.1Gemini (model)Claude (model)
Boxed warningFoundFoundPartial
Warnings & precautionsPartialPartialFound
ContraindicationsOmittedOmittedPartial
Adverse reactionsOmittedPartialOmitted
Illustration only: fictional product, invented scores, quotes, and verdicts. Named engines are layout examples, not measured results or affiliations. The downloadable sample is a separate reproducible example.
Finding 03 · Omitted
C1 · weight 2.0

Contraindications

Illustrative answer
“Tarquent may be used in adults when clinically appropriate.”
Illustrative safety information
“Contraindicated in patients with a history of serious hypersensitivity.”
Finding destination
Pharmacovigilance review
The report records the evidence and destination. Your team decides what happens next.
The sample report demonstrates the format using a reproducible fictional example.Open the sample report →
How monitoring works

Observe. Compare. Act. Re-measure.

Monitoring starts with a defined set of patient and clinician questions. Each capture records the engine and model, retrieval mode, timestamp, answer, and available citations. The monitoring plan states which surfaces are included.

01
Observe
Capture answers to patient and clinician questions, with available citations and a dated record.
02
Compare
Your team reviews differences from your own communications. Label Substantiation adds versioned label evidence.
03
Act
Decide what needs attention. Assign an owner and respond through your own teams and channels.
04
Re-measure
Repeat the questions at the agreed cadence. Compare later answers with the earlier evidence.
Monitoring over time

Snapshots make change visible.

The value is not a single answer. It is seeing which safety elements appear, disappear, or stay missing as the same questions are checked on schedule.

Tarquent · coverage history
One product, checked on a cadence.
Illustrative example · fictional product
Latest snapshot
58.1%
14 of 22 required elements present
Snapshot 001 · 2026-08-23
Coverage history
Snapshot 001
2026-08-23
Next scheduled
comparison
Later snapshot
change logged
A dated comparison shows what changed, and which omissions remain.
Who reads it

One report. Four questions it answers.

Commercial, medical, regulatory, and Pharmacovigilance each arrive with a different question. They all read the same dated report.

COMMERCIAL & BRAND
“What’s our exposure, and is it moving?”
Dated answers and cited sources per product and monitored surface, with snapshots available for comparison.
MEDICAL AFFAIRS
“What will the field be asked next?”
The questions AI answers incompletely today may be the questions your MSLs and medical information team field tomorrow.
REGULATORY & LEGAL
“Can we show we were looking?”
A dated record of what was checked, which source version was used, and what was found.
PHARMACOVIGILANCE
“Which required element is missing?”
Each finding is mapped to the relevant safety section, so your team can start with the missing element.
Scope your monitoring

Set the scope: products × cadence.

Monitor one product, several products, or a portfolio on the cadence that fits your review calendar.

Products
One → portfolio
Cadence
Weekly → review calendar
Output
Dated Safety Coverage Reports
Products in scope
One, several, or a portfolio.
Start where the questions matter most and expand the product set from there.
Monitoring cadence
Weekly, monthly, or aligned to review.
Choose how often the same questions come back for comparison.
Report content
Answers, label evidence, and history.
Review captured answers and cited sources alongside available label judgments and verbatim evidence. Missing or unverified evidence remains identified as such.
Start with a product and a question.
✓No customer data required✓Nothing to integrate✓No customer systems to connect✓No promotional content created✓One page to sign
We’ll scope the number of products and the monitoring cadence from there.
Why it matters

An answer can sound complete while leaving out required safety information.

Patients and clinicians ask AI about medicines. A fluent answer can still omit a contraindication, warning, or adverse reaction.

Fluent is not complete

A confident, well-written answer can look complete while leaving out the element that matters to one patient.

The gap is hard to see

Without comparing the captured answer with the required safety information, an omission stays hidden inside otherwise useful information.

The question is arriving now

The record gives your teams a shared place to start when they ask what AI answers are currently showing.

Why now

AI is becoming part of the information path. The standard for safety information is not changing.

AI is moving into clinical practice. At the same time, regulatory attention remains focused on how risk is presented and what material facts are omitted.

AI use in clinical practice
63%

of physicians surveyed in November 2025–January 2026 reported using AI in clinical practice, compared with 47% in the March–April 2025 cohort.

Doximity State of AI in Medicine 2026 · 3,151 US physicians across both cohorts; 54% overall
FDA promotional enforcement letters
74

King & Spalding counted 74 FDA drug-promotion enforcement letters in 2025, including two from CBER; this is not an OPDP-only count.

VizLoop gives teams a dated way to inspect what the answer says, what required safety information it leaves out, and what changes over time.

Answer Integrity
Pharma visibility needs label context.
A product mention cannot tell your team whether the answer carries a contraindication. Inspect the answer, its citations, and the versioned label together.
See the pharma difference →
When something is missing

See the finding. Route it. Re-measure.

Review the label judgment and its evidence, then assign a finding to a named owner. Compare it with a later snapshot when available.

01
Detect
A label judgment flags a safety element for review.
02
Document
Answer excerpt, required safety information, timestamp, and source version stay together.
03
Route
Your team assigns the finding to a named owner or queue.
04
Re-measure
Repeat the same questions at the agreed cadence. Compare the dated records when available.

Put Visibility and Label Substantiation to work.

Tell us the product and your review question. We’ll discuss the monitored surfaces, label comparison, cadence, and deliverable with your team.

No confidential information is needed to request a sample.