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Therapy Area Medical Writing, Statistics and Regulatory Documentation
Pubrica supports pharmaceutical and device teams, sponsors and investigators with medical writing, statistical analysis, regulatory documentation, health economics and publications, organised by therapy area. A single programme can include the protocol, statistical analysis plan, clinical study report, dossier modules and the publications that follow. We assign writers by indication, so each project is handled by someone familiar with the study designs, reporting guidelines, regulatory pathway and journals in that area. The areas below are those where we hold standing expertise. If your indication is not listed, contact us: we will tell you whether we have a matched expert, and decline if we do not.
Study design, endpoints, reproducible analysis outputs, ICH-structured documents and related publications.
- Assigned by indication
- One named lead throughout
- Reporting guideline identified
- Mutual NDA on request
- You are the author or sponsor
Service Scope
One project lead from protocol to publication
Each therapy area has its own endpoints and reporting guidelines. In every programme, a lead who knows the guideline your design requires checks whether each endpoint supports the claims made from it.
Protocol
Design and endpoints
Study design, endpoints and the statistical analysis plan developed together.
Analysis
Reproducible outputs
Reproducible code and outputs a reviewer can trace back to the dataset.
Clinical study report
ICH E3
Clinical study reports structured to ICH E3, including narratives and appendices.
Dossier
Modules 2.4 and 2.5
CTD clinical overviews and summaries, and the HTA submissions based on them.
Publications
Timed to data readouts
Congress abstracts and primary manuscripts, under ICMJE authorship.
Throughout
One named lead
A designated project lead keeps data interpretation and messaging consistent across regulatory documents and manuscripts.
Therapy areas
Sixteen therapy areas we support
Each card lists the typical study types and documents in that area. If your indication is not listed, contact us.
Clinical areas
Clinical areas we cover
Each clinical area has its own study designs and reporting guidelines, and we assign writers on that basis.
Life sciences and beyond
Five further disciplines with their own standards
These areas sit outside the clinical set and follow different reporting and regulatory standards.
Who We Serve
Teams we support by therapy area
Sponsors, device teams and payer-facing teams organise evidence by therapy area. The free scoping read is written for the team that requests it.
Teams we work with
Core Workstreams
Four workstreams, adapted to each therapy area
Endpoints, guideline extensions and assessing agencies vary by therapy area. The core services stay the same.
Four workstreams, in every therapy area
Area-Specific Requirements
Four requirements that vary by therapy area
This is why we assign writers by sub-specialty rather than by general medicine.
What moves between therapy areas
Our compliance and guideline standards
Guidelines applied at the current edition
We apply the guideline and extension your design requires and record the edition used. Writing to the current edition reduces the risk of findings linked to superseded guidance.
Standards we apply
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.
Sample work
Sample deliverables
Published where the client agreed, redacted where they asked.
Benefits
Benefits of indication-matched teams
What clients receive on every programme.
What you get
Therapy area or subject area?
Choosing the right list
This page organises our expertise by therapy area, as industry teams do. The subject areas page organises it by academic discipline.
What you came for, and where it is
Therapeutics FAQs
Questions about therapy areas and matching.
If your question is not answered here, ask an expert. No quote is required.
A subject area is the academic discipline — cardiology, microbiology, genomics. A therapy area is how industry organises evidence around an indication, and it cuts across disciplines: a vaccine programme needs immunology, epidemiology, statistics and regulatory writing at once. Most academic authors want the subject list; most pharma and device teams want this one.
Contact us. The list covers areas where we hold standing expertise, not every area we work in. For an unusual indication we will tell you whether we have a subject matter expert, and decline if we do not. If the closest match is an expert in an adjacent field, we say so.
Yes. A designated project lead coordinates the protocol, statistical analysis plan, clinical study report and publications in your therapy area to keep data interpretation and messaging consistent.
Yes, including the extensions. CONSORT has extensions for pilot, cluster and non-inferiority trials; oncology adds RECIST; prediction models add TRIPOD+AI. We confirm the correct extension in the scoping read.
Specific enough that the expert can question the analysis. For a trial that usually means the sub-specialty; for a broad review, the discipline is often enough. We will tell you which we have before you commit.
Yes. Animal studies are reported to ARRIVE 2.0, which journals increasingly check. We pay particular attention to sample size justification and randomisation reporting, where animal manuscripts most often fall short.
Device and diagnostic work follows its own regulation: clinical evaluation under MDR and performance evaluation under IVDR, reviewed by a notified body rather than a journal. It is covered on our device and IVD pages and handled by a separate team from trial manuscript editing.
Yes, contact us. Our panel covers many areas not named on this page. If we do not have a suitable subject match, we will tell you rather than assign someone from an adjacent field as a specialist.
Discuss your therapy area project requirements
Tell us your indication and deadline. The free scoping read takes two business days and gives you a written view of what the programme needs and who would lead it, including whether our closest expert is in your sub-specialty or an adjacent one.