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Pre-screen medical communications content for language patterns and claim structures that may raise promotional compliance concerns — helping you identify and address potential issues before content reaches formal MLR (Medical, Legal, Regulatory) review.
Risk tier: High  ·  Review requirement: Expert review by a compliance-qualified reviewer; formal MLR review required before any promotional useThis workflow is a pre-screening support tool, not a compliance determination. A clean pre-screen does not mean the content is compliant. Formal compliance sign-off is the responsibility of qualified Medical, Legal, and Regulatory professionals.

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What AI does

  • Scans text for superlative and comparative language that may require substantiation
  • Identifies potential off-label implications or suggestions
  • Flags areas where fair balance may be insufficient
  • Detects language patterns commonly raised in MLR review (unqualified superiority claims, emotive language, implied guarantees)
  • Highlights inconsistencies between claims and cited references

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What AI cannot do

AI cannot determine whether a flagged item is genuinely non-compliant in context, apply the correct market-specific advertising code, make a fair balance determination, or sign off content as compliant. These require qualified human reviewers.

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Before you start

  • Use this workflow on near-final drafts. Running pre-screening on rough drafts generates noise and provides limited value.
  • Know which advertising code or regulatory framework applies. MedCheckr flags general patterns — market-specific requirements need market-specific expertise.
  • Have the approved prescribing information (SmPC or USPI), the approved indication, and any approved messaging framework available for reference.
This workflow and the tools it references do not provide legal, regulatory, or compliance advice. Formal compliance determination is the responsibility of qualified Medical, Legal, and Regulatory professionals.

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Steps

1

Prepare a near-final draft

Compliance pre-screening is most valuable when the content is close to its final form. Running it on early drafts generates flags for issues that will be revised anyway.
2

Identify the applicable code and context

Confirm which advertising code or regulatory framework applies (e.g., ABPI Code, IFPMA Code, FDA promotional regulations). Specify this when running the pre-screen.
3

Run MedCheckr

Submit the content to MedCheckr for automated compliance signal scanning. Provide the product, approved indication, target audience, and intended channel.
4

Review flagged items in context

Assess each flag against the applicable code and the approved messaging framework. Not every flagged item is a genuine issue — a superlative is acceptable if substantiated; a comparative claim is acceptable if correctly referenced.
5

Verify claims against references

Use RefCheckr or the Verify Claims workflow to confirm that the claims underlying any compliance flags are supported by cited references.
6

Revise as needed

Address genuine compliance concerns. Distinguish between high-priority issues (potential off-label claim, unsupported superiority) and lower-priority style concerns.
7

Document changes

Record what was flagged, what was changed, and why. This documentation is useful if questions arise during MLR review.
8

Proceed to formal MLR review

Submit the revised content through your standard approval process. Pre-screening supports MLR — it does not replace it.

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Prompt pattern

You are a medical communications compliance review assistant. Your task is to pre-screen the following content for potential promotional compliance issues.

Content to review:
[INSERT CONTENT]

Product: [SPECIFY]
Approved indication(s): [SPECIFY]
Target audience: [SPECIFY — e.g., oncologists, general practitioners]
Intended channel: [SPECIFY — e.g., detail aid, leave piece, HCP website, conference stand]

Review the content for:
1. Superlative or comparative claims that may require substantiation
2. Language that implies efficacy or outcomes beyond what is supported by the cited references
3. Potential off-label implications or suggestions
4. Areas where safety information may be insufficient relative to efficacy claims (fair balance)
5. Emotive or promotional language that may not be appropriate for the content type
6. Claims that appear to extend beyond the approved indication
7. Unqualified statements that may need hedging or qualification based on the evidence

For each issue found:
- Quote the relevant text
- Describe the potential concern
- Suggest what type of revision may be needed
- Rate the concern: LOW / MEDIUM / HIGH

Rules:
- Flag potential issues for human review. Do not make definitive compliance determinations.
- Consider the content type and audience when assessing.
- If you cannot determine whether something is an issue without access to the full reference, flag it for verification.

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Understanding pre-screen output

Potential off-label claim, unsupported superiority statement, or significant fair balance gap. Resolve before proceeding to MLR review. Discuss with your regulatory or medical reviewer.

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Human review checklist

  • All flagged items have been assessed in context by a qualified reviewer
  • Superlative and comparative claims are substantiated by cited references
  • Fair balance of efficacy and safety information is appropriate for the content type and audience
  • No off-label implications or suggestions are present
  • Claims are consistent with the approved indication(s)
  • Language is appropriate for the content type and channel
  • Prescribing information or SmPC references are included where required
  • Content is consistent with any approved messaging framework or claims matrix
  • Changes made during pre-screening are documented
  • Content is ready for formal MLR review

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Common failure modes

RiskWhat to look for
Over-reliance on pre-screeningA clean MedCheckr scan does not replace your own compliance review — it supplements it. A clean scan means the tool found nothing, not that nothing is there.
False positivesExpect MedCheckr to flag valid, substantiated language. Each flag is a prompt to check, not a finding.
Market-specific gapsPre-screening tools catch general patterns but may miss market-specific code requirements — have a reviewer with the appropriate local expertise assess results
Evolving regulationsCheck results against the current published code — tool training data may not reflect recent updates

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Relevant tools

MedCheckr

Primary tool — automated compliance signal detection.

RefCheckr

Supporting tool — verify that promotional claims are supported by cited references.

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Next steps

Verify Claims

Confirm claims are reference-supported before MLR submission.

Final Review

Complete the QC process before the deliverable enters the approval queue.