Plain Language Summary Writing for Sponsors and Research Teams
Pubrica writes plain language summaries of clinical trial results for sponsors and research teams. Our plain language writers prepare lay summaries to EU CTR Annex V for trial participants and the public. Each summary covers the mandated content, can be understood by a non-specialist and remains non-promotional when the result is positive. You receive a readability-tested summary prepared for posting, with localised versions where the trial ran in several countries.
- All Annex V content elements, including those most often omitted, such as whether further trials are planned
- Non-promotional wording when the result is positive, because a summary that reads as marketing does not meet the requirement
- Reading level tested, rather than assumed to be plain once technical terms are removed
- Prepared to the CTR deadline: 12 months after end of trial for adults, 6 months for paediatric trials and up to 30 months for non-therapeutic Phase I
- Translation and localisation where the trial ran in several countries, adapted for each audience rather than translated literally
Annex V lay summaryIncluded
Readability testingIncluded
Non-promotional reviewIncluded
Translation and localisationQuoted separately
Posting to CTISFiled by your responsible party
Results → simplified → tested → reviewed → summary
- All Annex V elements covered
- Non-promotional wording, reviewed
- Reading level tested
- Deadline dated on the order
- Localised rather than literally translated
Deliverables
Plain Language Summary Deliverables
Each summary reports one trial and its result for a lay audience, and every statement stays within what the trial found.
Example from a content checkThe two elements most often missing are the comment on the outcome and whether further trials are planned. Both are required, and our content check confirms that both are included.
Example from a tone reviewThe study drug was highly effective and well tolerated.People who took the study drug were less likely to be admitted to hospital again within a month: 12 in every 100, compared with 16 in every 100 who did not take it. This wording is accurate and non-promotional.
Example from a readability reviewThe primary endpoint was met with statistical significance (p=0.01).The main thing we wanted to find out was whether the drug reduced hospital readmissions. It did. The difference was big enough that it is unlikely to be chance.
Example from a project scheduleThe deadline runs from the end of trial regardless of whether the manuscript is ready or the database is fully cleaned. It is a separate obligation from publication.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Plain Language Summary Regulatory and Readability Standards
The regulation sets the required content and deadline, and plain language practice sets the readability standard.
Clinical Trials Regulation (Annex V)
Sets the ten mandated content elements for the lay summary and the deadlines: 12 months for adult trials, 6 months for paediatric trials and up to 30 months for non-therapeutic Phase I.
Clinical Trials Information System (transparency rules)
The system where the summary is posted. EudraCT is the legacy system, so any process that still refers to it needs updating.
Plain language practice (readability testing)
Covers reading level, sentence length, natural frequencies and the ordering that makes a result understandable to a non-specialist.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our quality management system governs how each document is drafted, reviewed, version-controlled and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a named individual. For this reason, source traceability takes priority over speed in our regulatory writing, and every statement must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our Plain Language Summary Writing Process Works
Our process keeps each summary accurate and non-promotional while making it understandable to a lay reader.
Source Review and Deadline Setting
We review the study report or top-line results, map the Annex V elements and calculate the deadline from the end of trial.
Drafting for a Lay Reader
We write result-first, using natural frequencies at the target reading level, and include the limitations rather than omitting them.
Non-Promotional and Accuracy Review
We check the draft against the source for accuracy and against the requirement for neutral tone, because a summary that reads as marketing does not meet the requirement.
Localisation and Delivery
Where the trial ran in several countries, we translate and culturally adapt the summary, then deliver it for posting under your responsible party.
Our Experts
Our Plain Language Summary Writing Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
Plain Language Summary Service Packages
Pricing depends on trial complexity and the number of languages. Translation is quoted per language.
Lay summary
Sponsors with a CTR disclosure obligation
Quoted per projectBased on trial complexity
Delivery Delivered to the CTR deadline
- ✓All Annex V content elements
- ✓Written result-first at the target reading level
- ✓Readability tested
- ✓Non-promotional review
- ✓Deadline dated on the order
- ✓One revision round
The deadline runs from the end of trial, not from when the publication is ready.
Deliverables Request a quoteSummary with localisation
Multi-country trials
Quoted per projectPer language · based on count and complexity
Delivery By language count
- ✓Everything in the summary
- ✓Translation into the required languages
- ✓Cultural adaptation rather than literal translation
- ✓Reading level checked in each language
- ✓Consistent terminology across versions
A literally translated lay summary reads as a translation and is harder for participants to follow.
Deliverables Request a quoteTell us the end-of-trial date and we will confirm the deadline: 12 months for adult trials and 6 months for paediatric trials. It is a separate obligation from publication.
FAQs
Plain Language Summary FAQs
If your question is not answered here, ask an expert. No quote is required.
Twelve months after the end of the trial for adult trials, six months for paediatric trials, and up to thirty months for non-therapeutic Phase I trials.
The deadline runs from the end of trial, not from publication or database lock. It is a separate obligation and is often missed when attention is on the manuscript.
It means the summary describes what the trial found without selling it. A positive result stated accurately is fine; the same result stated enthusiastically is not.
In practice, adjectives are the main indicator. “Effective” is a judgement, whereas “12 in every 100 compared with 16 in every 100” is a finding, and the finding is also more useful to a participant.
No. A simplified abstract is written for a scholarly or professional audience and is a publication deliverable. A lay summary under Annex V is a legal deliverable written for trial participants and the public.
The two documents differ in audience, register and content requirements, and only the lay summary has a statutory deadline. They are sometimes ordered together, but they are separate documents.
We prepare it for posting. The record is filed on your account under your responsible party, as with all registry disclosure.
If you would like the posting handled, this is covered by our clinical trial support service, which includes registry records and results disclosure.
Related Services
Related Clinical Trial Disclosure and Publication Services
Trial disclosure, publication and participant communication are separate obligations that arise from the same trial.
1TRIAL DISCLOSUREregistry obligations
Clinical trial supportRegistry records and results disclosure. Clinical study reportThe full study report to ICH E3.2PUBLICATIONscholarly audience
Simplified abstractFor a scholarly readership. Original research articleThe manuscript, to CONSORT 2025.3PATIENT COMMUNICATIONplain language
Patient education contentContent written for patients and the public. Informed consent formPlain language with readability testing.Request a Free Lay Summary Deadline Check
We will confirm the deadline for your trial: 12 months for adult trials and 6 months for paediatric trials. It is a separate obligation from publication.