Description
Plain Language Summary (PLS) Development
Patient-friendly plain language summaries that meet EU Clinical Trial Regulation (CTR) requirements and journal publication standards. We communicate clinical research in accessible, jargon-free language for lay audiences, including study participants.
Service Details
| Turnaround | Standard: 2-3 weeks | With patient review: 4-5 weeks |
| Reading level | 6th-8th grade, with Flesch-Kincaid readability verification |
| PLS types | EU CTR lay summary, journal PLS, patient-facing results, visual abstracts |
| What you receive | A designed, translation-ready master |
Regulatory Requirements
- EU CTR (536/2014) – Mandatory lay summary requirement
- Health Canada – Plain language summary guidance
- GPP 2022 – Patient engagement standards
- INVOLVE – Patient involvement in research
PLS Types
- EU CTR Lay Summary – Regulatory requirement for EU trials
- Journal PLS – Publication accompanying summary
- Patient-Facing Results – Study participant communications
- Visual Abstracts – Infographic summaries
Development Process
- Content development at 6th-8th grade reading level
- Flesch-Kincaid readability verification
- Patient reviewer input (optional)
- Visual design and layout
- Translation-ready master
Quality Features
- Jargon-free language
- Clear benefit-risk communication
- Accessible formatting
- Multi-language support
How It Works
- Send us your study results or manuscript and tell us which PLS type you need
- We draft the summary at a 6th-8th grade reading level and verify readability with Flesch-Kincaid
- You review the draft (with optional patient reviewer input) and we revise it based on the feedback
- You receive the final summary with visual design and layout, as a translation-ready master
Which Service Do You Need?
This service is built for EU CTR lay summaries and journal PLS from clinical research. For a general research summary for non-specialist audiences, of the kind many journals and funders request, see Plain Language Summary. For patient-facing consent documents, see Informed Consent Form (ICF) Development.
Frequently Asked Questions
Which requirements does the summary meet?
The EU CTR (536/2014) mandatory lay summary requirement, Health Canada plain language summary guidance, GPP 2022 patient engagement standards, and INVOLVE (patient involvement in research).
What reading level do you write to?
A 6th-8th grade reading level, verified with Flesch-Kincaid readability scoring.
How long does it take?
Standard turnaround is 2-3 weeks, or 4-5 weeks with patient review.
Is patient review included?
Patient reviewer input is optional. Choosing it extends the timeline to 4-5 weeks.
Can the summary be used in other languages?
The summary is delivered as a translation-ready master, and multi-language support is available.
Get started: add this service to your cart, or email co*****@*******se.com with your study results and the PLS type you need.
