Plain language summaries, at portfolio scale.

The obligation to deliver a plain language summary clinical trial participants can trust sits with the sponsor, but the drafting can be shared. TrialAssure LINK® AI produces the first draft from your results data, then professional medical writers — ours or your own — review every statement for scientific accuracy and readability before sign-off; translation and delivery follow in the same pipeline. This is the named, published workflow Daiichi Sankyo runs, reporting PLS delivery up to 80% faster at around 50% lower cost per document. AI removes the blank page. It does not remove the writer, or the accountability that comes with the byline.

A layperson summary of the results, submitted to CTIS within 12 months of trial end — 6 months where the trial includes pediatric participants. Content follows the 10 elements of Annex V to Regulation (EU) No 536/2014 — among them what the trial looked at, who took part, what was found, what side effects occurred, and where to read more. The order can change; the coverage cannot. It is submitted alongside the Annex IV scientific summary, in the local official language(s) of each participating country as EU guidance recommends, and Good Lay Summary Practice sets the readability bar.

That’s the design: AI produces the draft, and your writers (or ours) make every decision and sign off. Cancer Research UK’s Centre for Drug Development runs it exactly that way, with its own medical writers central to every review. LINK AI drafts inside Microsoft Word on your own templates, and each generated statement carries a reference back to the source it came from — so a reviewer verifies a claim instead of trusting it. Every transformation is logged and attributable. That is what AI Enabled. Human Driven.™ means in practice.

Yes. Drafting, medical-writer review, translation into the local official language(s) of your trial countries, and delivery run as one pipeline — so a lay summary doesn’t stall waiting on a separate translation vendor. Good Lay Summary Practice treats translation into every trial-country language as good practice and expects translated versions to be readable, not merely accurate, which is why they warrant user testing rather than a back-translation check alone. Scope the language list at protocol stage: languages discovered late are what turn a comfortable 12-month clock into a missed one.

Results summaries first — that is the EU CTR deliverable — but also plain language versions of publications, protocols, and informed consent forms. LINK AI covers the whole family because the underlying job is the same: restate a technical source document at a lay reading level without changing what it says or adding anything it does not support. Only the results summary is a legal obligation under Article 37(4); the others are usually driven by journal policy, patient-group commitments, or ethics committee expectations.

Every interventional clinical trial of a medicinal product conducted in the EU/EEA under Regulation (EU) No 536/2014 owes a lay summary — irrespective of the trial’s outcome. That includes low-intervention trials and trials that stop early: under Article 37(7), the early-termination date becomes the end-of-trial date and starts the same 12-month clock (6 months where pediatric participants are involved). Non-interventional studies and trials run entirely outside the EU/EEA fall outside Article 37(4).

Missing the deadline is an infringement each Member State can penalize under Article 94 of the EU CTR, which requires penalties that are ‘effective, proportionate and dissuasive’ and explicitly names failure to submit information intended for the public EU database. There is no EU-level fine schedule — exposure varies by country. The gap is also visible: CTIS publicly shows each trial’s end date, so an overdue summary is plain to regulators and patients. TrialAssure REGISTRY exists to keep that queue visible before it becomes a finding.

Immediately on submission, in most cases. Since the revised CTIS transparency rules took effect on 18 June 2024, results documents are published as soon as the sponsor uploads them — the old deferral mechanism is gone, and redaction is the only remaining protection for personal data and commercially confidential information. The one exception: results of ‘Category 1’ trials conducted solely in adults are published 30 months after the EU/EEA end-of-trial date.

Only if the protocol already provides for it. Article 37(4) permits later submission solely for scientific reasons detailed in the protocol — the protocol must specify when results will be submitted and justify why, and the summary is then due as soon as it is available. There is no discretionary extension request after the fact. Separately, Article 37(8) adds a clock: if the protocol sets an intermediate data analysis date, a summary of those results is due within one year of that date.

Understandable to readers aged 12 and up, per the EU Expert Group recommendations adopted in Good Lay Summary Practice (GLSP, EudraLex Volume 10, October 2021). GLSP calls for conversational language, health-numeracy principles — whole numbers, consistent denominators, no calculations left to the reader — user testing with laypeople, and readability formulas like Flesch–Kincaid only as a supplement. TrialAssure LINK AI drafts to these health-literacy standards, with medical writers reviewing every summary before it ships.

No. Regulation 536/2014 does not itself mandate translations. The EU Expert Group on Clinical Trials recommends, at minimum, the local official language(s) of each country where the trial took place, matching the languages of the Patient Information Sheet and Informed Consent Form — and GLSP treats translation into all trial-country languages as good practice, with user testing of translated versions. An English version is suggested where resources allow, for accessibility across the EU.