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Psychiatry and Mental Health Medical Writing and Regulatory Documentation
Pubrica supports sponsors, clinical researchers and investigators in psychiatry and mental health with medical writing, statistical analysis, regulatory documentation and publications. Projects include trials with rating-scale endpoints, pragmatic trials, cohort studies and instrument validation work, often with outcomes reported by patients. We prepare protocols, statistical analysis plans, clinical study reports, submission summaries and manuscripts, including assessment of whether blinding was maintained when noticeable side effects may reveal treatment allocation. 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
Psychiatry and mental health study types, guidelines and analysis issues
Psychiatric trials rely on rating scales and patient-reported outcomes, and blinding can be difficult to maintain. The study design determines the reporting guideline and the points assessors and payers examine.
Typical study types
Typical study types
Trials with rating-scale endpoints, pragmatic trials, cohort studies and instrument validation work.
Reporting guidelines
Guidelines and extensions applied
CONSORT 2025 with the non-pharmacological extension, COSMIN for measurement properties, and ICH E9(R1) for estimands.
Key analysis issue
Points reviewers examine closely
Whether blinding was maintained. When side effects are noticeable, participants often guess their allocation, which can affect self-reported outcomes.
Common review points
Common review points in psychiatry and mental health submissions
Psychiatry and mental health submissions are often questioned on the points below. We review them on every programme in this area before filing.
Points we check before filing
Services for this area
Services for psychiatry and mental health 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 psychiatry and mental health
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 psychiatry and mental health 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.
Psychiatry & mental health FAQs
Questions from psychiatry and mental health teams
Yes. Leads are assigned by indication and have worked in this area. They know that whether blinding was maintained, given noticeable side effects and self-reported outcomes, 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 psychiatry and mental health work this is usually CONSORT 2025 with the non-pharmacological extension, COSMIN for measurement properties, and ICH E9(R1) for estimands. 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.
Scale scores treated as interval data without stating this, and change scores analysed without baseline adjustment. We check this on every psychiatry and mental health programme before filing, when it is easier and less costly to correct.
Payers increasingly ask for functional and work-participation outcomes, not only symptom scores. 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 psychiatry and mental health programmes
When a programme spans two therapy areas, we assign a lead for each area.
Other therapy areas
Discuss your psychiatry and mental health project requirements
Share your indication and timeline. The free scoping read takes two business days and gives you a written view of what your psychiatry or mental health programme needs and who would lead it.