CTD Module 2.5 and 2.7 Summary Writing for Sponsors
Pubrica writes CTD Module 2.5 clinical overviews and Module 2.7 clinical summaries for sponsors preparing regulatory submissions. Module 2.5 is a critical assessment of the clinical programme, and Module 2.7 is the detailed factual summary that supports it. Reviewers read Module 2.5 first and often decide there how closely to read the rest of the dossier, so it should present the case for your product rather than summarise the study reports. Our regulatory medical writers prepare both modules from the underlying reports, so that the numbers agree and the conclusions are supported by the data.
- 2.5 written as a critical assessment rather than a digest, setting out the benefit-risk case across the programme and addressing its weaknesses directly
- 2.7 built by extraction where the underlying reports were written for it, which removes an entire round of reconciling two versions of the same numbers
- Consistent across the dossier, because a number that differs between 2.5, 2.7 and the study report leads to questions and an additional review cycle
- Integrated summaries alongside where ISS and ISE are in scope, written with the pooled analysis rather than after it
- Organised in the order reviewers read, which is not necessarily the order in which the programme was conducted
Module 2.5 clinical overviewIncluded
Module 2.7 clinical summaryIncluded
Integrated summaries (ISS/ISE)Quoted with the analysis
Cross-document consistency checkIncluded
eCTD publishing and submissionYour regulatory operations team
Study reports → pooled → summarised → argued → modules
- Written from the underlying reports
- 2.5 written as a critical assessment
- Numbers reconciled across documents
- Weaknesses addressed directly
- Organised in the reviewer’s reading order
Deliverables
Four Deliverables Included in Every Module 2.5 and 2.7 Set
Each module set presents one benefit-risk case for one programme, and what the studies collectively show determines what Module 2.5 can conclude.
From Module 2.5The clinical programme supports the proposed indication.Two adequate and well-controlled trials, consistent in direction and magnitude; the inconsistency in the elderly subgroup is addressed directly, and the proposed labelling reflects it.
From the buildWhen the summary is written separately by a different team, the two documents often describe the same analysis in incompatible terms, which then have to be reconciled under submission pressure.
From the reviewModule 2.5 is the document in which you control how a limitation is presented. Omitting a limitation does not remove it; it becomes a question that must be answered within a response deadline.
From the consistency checkNumber discrepancies between documents are among the most common and most avoidable questions in a submission, and they are time-consuming to correct once raised.
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Compliance and Standards
Four Regulatory References for CTD Module 2.5 and 2.7 Summaries
Where your regulatory agency or house template has stated a position, we follow it.
Common Technical Document (clinical overview and summary)
The structure and expected content of Module 2.5 and Module 2.7, and how they relate to the study reports in Module 5.
Clinical study report structure (with the 2012 Q&A (R1))
The source documents from which the summaries are built. Reports written for reuse make the summaries quicker to prepare and more reliable.
Statistical principles with estimands (E9(R1), 2019)
The estimand is carried from the analysis plans through the reports into the summaries, so that the efficacy claim is consistent at every level.
Quality management (cert. H3CR9TCU20251212INDQM10N)
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 evidence and to a responsible individual. Our specialists therefore treat source traceability as more important than speed, and every statement in a document must be supported by a traceable source.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI tools are usually reported by the companies that sell them.
For this reason, Pubrica does not quote an accuracy figure of its own, as it would carry the same conflict of interest. We tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our CTD Module 2.5 and 2.7 Writing Process Works
We write the summaries from the study reports and write the clinical overview last.
Source review across the programme
We read every study report, the integrated summaries and the statistical outputs to establish what they show together and where they disagree.
Module 2.7 assembly
We build the clinical summary by extraction where the reports allow it, with every figure traced to its source.
Module 2.5 drafting
We write the critical assessment last, once the findings of the programme are settled, including any results that are weaker than expected.
Consistency and review
Numbers and terminology are reconciled across Module 2.5, Module 2.7, the integrated summaries and the study reports, and your review comments are consolidated in each cycle.
Our Experts
Our CTD Module Writing Team
The same named team of regulatory specialists works on your project from scoping to delivery, and your project coordinator introduces each member 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. The 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
Two CTD Module Writing Service Options, Quoted per Project
Cost depends on programme size, the number of studies and whether integrated summaries are included.
Module 2.5 and 2.7
Sponsors assembling a submission
Quoted per projectOn study count and programme size
Delivery By scope
- ✓Module 2.5 clinical overview with a reasoned benefit-risk case
- ✓Module 2.7 clinical summary
- ✓Every figure traced to source
- ✓Cross-document consistency check
- ✓Weaknesses addressed in the overview
- ✓Three review cycles
Both modules are written together, which keeps them consistent with each other.
Deliverables Request a quoteModules with integrated summaries
Programmes where ISS and ISE are in scope
Quoted per projectOn pooled analysis scope
Delivery By scope
- ✓Everything in the module set
- ✓Integrated Summary of Safety
- ✓Integrated Summary of Efficacy
- ✓Written alongside the pooled analysis rather than after it
- ✓One terminology and numbers base across the submission
Integrated summaries written after the pooled analysis is complete usually have to be revised, so we write them alongside it.
Deliverables Request a quoteSend us one study report and we will assess, free of charge, how much of Module 2.7 could be extracted rather than rewritten. This is useful to know before the next report is written.
FAQs
CTD Module 2.5 and 2.7 FAQs
If your question is not answered here, ask an expert. No quote is required.
2.7 is the detailed factual summary of the clinical data. 2.5 is the critical assessment — the argument for why that data supports the proposed indication and labelling.
The most common mistake is writing Module 2.5 as a shorter version of Module 2.7. Module 2.5 is the only place in the dossier where you present the case in your own words, and a summary does not use that opportunity.
After, and ideally by writers who have read the full reports rather than summaries of them. Where the reports were written for reuse, Module 2.7 is largely extracted from them.
If a programme is still running, it is worth writing the reports with the summaries in mind, because this is the most economical time to do so.
Yes. A reviewer will find an inconsistent subgroup or an underpowered comparison, and it is better that they read about it in your own explanation.
Addressing a limitation in Module 2.5, with the proposed labelling reflecting it, is a stronger position than responding to it as a deficiency within a response deadline.
No. eCTD compilation and submission through the gateway sit with your regulatory operations function or a publishing provider, and require licensed software and agency accounts.
We write the content, and your publishing team or provider compiles and submits it. We do not provide publishing ourselves, and we will tell you when you need a publishing partner.
Related Services
Related Regulatory Writing Services
The summaries are built from the study reports and are the first part of the clinical dossier that reviewers read.
1SOURCE DOCUMENTSwhat the summaries are built from
Clinical study reportTo ICH E3, written for reuse. Patient narrativesDeaths, SAEs and discontinuations.2SUBMISSION DOCUMENTSother parts of the dossier
Regulatory writingDossiers, briefs and submissions. Health authority responseResponses to agency questions.3STATISTICAL ANALYSISpooled and per-study
BiostatisticsPooled analysis and integrated summaries. Meta-analysisPooled estimates across the programme.Request a Free Module 2.7 Extraction Assessment
We will assess, free of charge, how much of Module 2.7 could be extracted rather than rewritten. This is useful to know before the next report is written.