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Respiratory Medical Writing, Statistics and Regulatory Documentation
Pubrica supports sponsors and clinical research teams in respiratory medicine with medical writing, statistical analysis, regulatory documentation and publications. Typical projects include trials with spirometry and exacerbation endpoints, inhaled device studies in which the device and the molecule are assessed together, and real-world effectiveness cohorts. We prepare protocols, statistical analysis plans, clinical study reports, CTD summaries and manuscripts, and analyse exacerbation rates with count models that account for over-dispersion and differing follow-up time. A designated project lead coordinates the protocol, analysis plan, study report and publications to keep data interpretation and messaging consistent.
We identify the reporting guideline and extension that fit your study design during the free scoping read.
- Assigned by indication
- One named lead throughout
- Reporting guideline identified
- Mutual NDA on request
- You remain the sponsor
Scope of Work
Respiratory study types, guidelines and analysis issues
Respiratory programmes combine lung-function and exacerbation endpoints with inhaler device documentation. The study design determines which reporting guideline applies and which analysis points reviewers and payers focus on.
Typical study types
Typical study types
Trials with lung-function and exacerbation endpoints, inhaled device studies and real-world effectiveness cohorts.
Reporting guidelines
Guidelines and extensions applied
CONSORT 2025 for trials, STROBE for cohorts, and device documentation where the inhaler is part of the product.
Key analysis issue
Points reviewers examine closely
Exacerbation rate analysis: whether the count model accounts for over-dispersion and differing follow-up time.
Common review points
Common review points in respiratory submissions
Respiratory dossiers and manuscripts are often questioned on the points below. We check each one on every programme in this area before documents are filed.
Points we check before filing
Services for this area
Services for respiratory programmes
Services are grouped by programme stage. 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 ordered individually or as a programme. A designated project lead coordinates the documents so that data and messaging stay consistent.
Who We Serve
Who we support in respiratory
The free scoping read is written for the team that requests it, whichever function it sits in.
Teams we work with
Our compliance and guideline standards
Guidelines applied at the current edition
Each deliverable names the guideline and extension your design requires, and the edition used. Writing to the current edition reduces the risk of findings linked to superseded guidance.
Standards applied in this area
Where AI is used, and where it is not
Used for search and formatting. Not used to write your science.
This policy applies in every therapy area and to every deadline.
Our AI policy
How it works
Five steps, starting with a free scoping read
We review your programme before providing a quote.
One
Scoping read
Free, within two business days: what the programme needs, who would lead it and the expected cost.
Two
Named lead
A lead matched to the indication is assigned before work starts and coordinates the programme throughout.
Three
Outline approval
Every section and its source, approved before drafting.
Four
Drafting and review
Independent review, QC and reference verification, each signed off separately.
Five
Handover
The deliverable with its working material, revised within the agreed scope.
After
Follow-up questions
Reviewer and health-authority questions are answered by the writer of the document.
Our Experts
Who works on respiratory projects
Writers are assigned by indication, not by availability. They hold a master’s degree or doctorate in life sciences, medicine or pharmacy and have at least five years in the field. Regulatory writers work to the guidance that governs each document.
Team roles
Sample work
Sample deliverables
Published where the sponsor agreed, redacted where they asked.
Benefits
Benefits of indication-matched teams
What clients receive on every programme.
What you get
Packages
Priced per programme, 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 read gives you a programme-level figure for your budget.
First
Scoping read
Free, two business days. A written assessment of what the programme needs.
Then
A written scope
Documents, standards, named team and timeline, agreed before work starts.
Quoted
Per programme
One price for the agreed scope, with revisions included within the agreed scope rather than billed per round.
Respiratory FAQs
Questions from respiratory teams
Yes. Leads are assigned by indication and have worked in this area. They know that exacerbation rate analysis, including over-dispersion and differing follow-up time, is a frequent review point and address it before the document is written, not after it comes back. If no one on our panel is a suitable match, we tell you and decline the project.
The study design determines the guideline, not the indication. For respiratory work this is usually CONSORT 2025 for trials, STROBE for cohorts, and device documentation where the inhaler is part of the product. We confirm the applicable extension in the free scoping read, because revising a finished report to a different guideline is harder than writing to it from the start.
Exacerbations analysed as simple rates without adjusting for differing exposure time, which can overstate or understate the effect. We check this on every respiratory programme before filing, when it is easier and less costly to correct.
Payers ask about adherence and inhaler handling, which trial conditions rarely reflect and dossiers often do not address. The scoping read identifies this early, while the evidence plan can still be adjusted.
Yes. A designated project lead coordinates the protocol, statistical analysis plan, clinical study report and publications to keep 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 Areas
Therapy areas often linked to respiratory programmes
When a programme spans two therapy areas, we assign a lead for each area.
Other therapy areas
Discuss your respiratory project requirements
Share your indication and timeline. The free scoping read takes two business days and gives you a written view of what your respiratory programme needs and who would lead it.