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Produce first-draft plain language summaries structured to common PLS frameworks — from clinical study reports, published papers, or results summaries. PLS Generator handles the structure and language translation so you can focus your review on accuracy, balance, and regulatory requirements.

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The problem it solves

Plain language summaries are now a regulatory requirement, not an optional nice-to-have. The EU Clinical Trials Regulation requires lay-friendly summaries of clinical trial results. Sponsors are increasingly publishing PLS for transparency and patient engagement. But writing an effective PLS is one of the hardest tasks in medical writing. You must translate complex study designs, statistical results, and safety profiles into language that a non-specialist adult can genuinely understand — without distorting the science or creating false reassurance. PLS Generator produces a structured first draft from your clinical source materials. You then verify medical accuracy, check readability, ensure balanced representation of benefits and risks, and confirm compliance with any applicable regulatory template requirements.

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How to use it

1

Provide the source material

Supply the clinical study report, published paper, or results summary. The more complete and clearly structured the source, the more accurately PLS Generator can represent the findings.
2

Specify the PLS requirements

Define the format, structure, target reading level, and any regulatory template requirements that apply. If the PLS is for EU CTR disclosure, specify this so the output aligns with those structural expectations.
3

Run PLS Generator

Generate a first-draft plain language summary structured to your specified requirements.
4

Review for accuracy

Verify that all data points, findings, and conclusions are accurately represented. Check that statistical results have not been simplified in a way that changes their meaning, and that the balance between benefits and risks is preserved.
5

Review for readability

Confirm the output meets the target reading level and is genuinely accessible to a lay reader — not just technically plain, but logically structured and free of implicit clinical jargon.
6

Expert review

PLS for regulatory submission or public disclosure must be reviewed by qualified professionals — medical, regulatory, and legal as appropriate to the submission context.
7

Patient and lay reader review

Where possible, test the summary with representative readers from the target audience. AI cannot replicate this feedback. Best practice for PLS includes lay reader testing, and many regulatory frameworks expect it.

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What it does well

  • Translates clinical trial results into structured, accessible language
  • Follows common PLS frameworks and structures
  • Handles standard clinical trial terminology and endpoint descriptions
  • Produces content at an appropriate reading level for lay audiences

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What it does not do

PLS for regulatory disclosure must meet specific requirements that vary by jurisdiction and submission type. PLS Generator produces drafts — compliance is the responsibility of the review team, not the tool.
PLS Generator produces drafts aligned to common PLS structures. Regulatory compliance for clinical trial disclosure — including EU CTR requirements — requires expert review and formal sign-off.
Best practice for PLS includes review by patient representatives or lay readers. PLS Generator can produce accessible language, but it cannot tell you whether real patients find the summary genuinely understandable. Build lay reader testing into your workflow.
Decisions about which results, endpoints, or findings to include in a PLS are made by the study team and medical writer. PLS Generator works with what you provide.
PLS may need to be produced in multiple languages for international disclosure. Translation is a separate process requiring qualified medical translators.

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Risk tier

Plain language summaries are medium-to-high risk, particularly when they are required for regulatory disclosure, intended for direct patient or public consumption, or summarising safety data and adverse event information. All PLS Generator output requires expert review and, where applicable, patient/lay reader testing. See the risk levels framework for full context.

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Workflow integrations

Create a plain language summary

Primary use. Generating structured PLS drafts as the core step in the plain language summary workflow.

Final human review

Always required. PLS for regulatory submission or public disclosure must pass a structured expert review gate.

Patiently AI

Related tool. Use Patiently AI when the goal is broader patient-facing language translation rather than a structured PLS document.

Verify claims against references

Supporting step. Use RefCheckr to verify that data points in the PLS are accurately drawn from the source.

Try PLS Generator at PharmaTools.AI

Part of the PharmaTools.AI toolkit for medical writing teams.