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Paediatric Medical Writing, Statistics and Regulatory Documentation
Pubrica supports sponsors, clinical research teams and principal investigators in paediatrics with medical writing, biostatistics and regulatory documentation. Typical projects include paediatric trials with age-appropriate endpoints, extrapolation studies, paediatric investigation plan (PIP) and paediatric study plan (PSP) submissions, and long-term follow-up cohorts. We prepare protocols, assent documentation, statistical analysis plans, clinical study reports and publications. A designated project lead coordinates these documents to keep data interpretation and messaging consistent. A key question is how far adult data can be extrapolated, for which endpoints and on what pharmacological basis. Paediatric obligations often begin earlier in development than teams expect.
We identify the reporting guideline that applies to your study design as part of the free scoping assessment.
- Writers matched by therapy area
- One designated project lead
- Applicable reporting guideline identified
- Mutual NDA on request
- You remain the named sponsor
Study Types and Standards
Typical paediatric studies, guidelines and analysis questions
Each therapy area has its own typical study designs, reporting guidelines and recurring analysis questions. We assign writers and statisticians to paediatric projects on that basis.
Study types
Typical projects
Paediatric trials, extrapolation studies, PIP and PSP submissions, and long-term follow-up cohorts.
The guideline
Applicable reporting standards
CONSORT 2025; ICH E11(R1) for paediatric development; ethics and assent documentation to the relevant national standard.
Key question
Common analysis question
Extrapolation from adults: how much adult data can be used, for which endpoint and on what pharmacological basis.
Common Review Points
Common review points in paediatric submissions
These are issues that reviewers, assessors and payers often raise on paediatric documents. We check for them during drafting and review.
Points we check
Our Services
Paediatric writing, statistics and regulatory services
Services are grouped by programme stage. Medical device and diagnostic work follows MDR and IVDR rather than ICH and is covered on the relevant industry pages.
59 services, by stage of the programme
Services can be commissioned individually or as a programme. A designated project lead coordinates the protocol, analysis plan, study report and publications to keep paediatric data interpretation and messaging consistent.
Who we serve
Teams we support in paediatrics
We work with these functions in sponsor organisations and research groups. The scoping assessment is written for the team that requests it.
Functions we support
Our compliance and guideline standards
Guidelines and standards we work to
Each project names the reporting guideline your study design requires and the edition used. We check that documents follow the current edition.
Standards applied in paediatric projects
Use of AI Tools
AI tools support search and formatting, not scientific writing
This policy applies to every therapy area and every deadline.
Our AI policy
How it works
Five steps, starting with a free scoping assessment
We review your requirements before providing a quote.
One
Scoping assessment
Free, within two business days. We set out what the project needs, who would lead it and the estimated cost.
Two
Project lead assigned
A lead with experience in the therapy area is named before work starts and stays with the project throughout.
Three
Outline approval
You approve each section and its sources before drafting begins.
Four
Draft and review
Independent review, quality control and reference verification, each signed off separately.
Five
Handover
You receive the deliverable with its working material. Revisions are made within the agreed scope.
After
Follow-up questions
Questions on a document are answered by the person who wrote it.
Our experts
The paediatric project team
Writers are assigned by therapy area, not by availability. They hold a master’s degree or doctorate in life sciences, medicine or pharmacy and have at least five years of experience in the field. Regulatory writers follow the guidance that applies to each document.
Specialists on paediatric projects
Sample work
Sample deliverables
Published with sponsor agreement and redacted where requested.
Benefits
Benefits of a therapy-area team for paediatric projects
Reasons clients give for continuing to work with us.
What you get
Packages
Pricing per project, not per page
A 4,000-word study report and a 4,000-word overview involve different work, so we do not price by word count. The free scoping assessment gives you a project cost you can use for budgeting.
First
Scoping assessment
Free, within two business days. A written assessment of what the project needs.
Then
A written scope
Documents, standards, named team and timeline, agreed before work starts.
Quoted
Per project
One price for the agreed scope, with revisions included rather than charged per round.
Paediatrics FAQs
Questions about paediatric projects
Yes. Projects are assigned by therapy area, and the lead has worked in paediatrics. They are familiar with common questions in this area, such as how far adult data can be extrapolated, and can flag likely reviewer comments before drafting starts. If no one on our panel is a suitable match, we will tell you and decline the project.
It depends on your study design rather than the therapy area. In paediatrics, the usual standards are CONSORT 2025 for trials, ICH E11(R1) for paediatric development, and ethics and assent documentation to the relevant national standard. We confirm the applicable guideline in the free scoping assessment, as writing to it from the start is easier than revising a report later.
Extrapolation assumed rather than justified, so a paediatric plan relies on adult data without explaining the bridge. We check for this on every paediatric project before submission, when it is easier to correct.
A paediatric investigation plan agreed late can constrain the whole programme. The scoping assessment flags this early, while the evidence plan can still include it.
Yes. A designated project lead coordinates the protocol, statistical analysis plan, clinical study report and publications to keep paediatric data interpretation and messaging consistent. Health-authority questions are answered by the writer of the document concerned.
We do not operate your pharmacovigilance system. We write the risk management plan and periodic reports, but case processing and reporting to authorities stay within your own PV system under your qualified person. We do not conduct trials, audit or certify GCP or GMP compliance, or claim authorship of your research. You remain the sponsor throughout.
Related Therapy Areas
Therapy areas often linked to paediatric programmes
Where a programme covers two therapy areas, we assign a lead for each area.
Other therapy areas
Discuss your paediatric project requirements
Tell us your indication and deadline. The scoping assessment is free and takes two business days. You receive a written summary of what the project needs and who would lead it.