Home/Industries/Contract research organisations
Medical Writing and Statistical Programming Support for CROs
Pubrica provides contract research organisations with additional medical writing and statistical programming capacity, working under your sponsor’s quality system and your templates. We prepare clinical study reports, patient safety narratives, CDISC SDTM and ADaM datasets, tables, listings and figures, and documents reviewed in sponsor audits. Work is delivered in your templates and under your SOPs, so it can be issued as your own deliverable.
Delivered in your templates, under your SOPs and your version control.
- Work under your sponsor’s QMS
- Your templates and SOPs
- Confidential subcontracting
- Mutual NDA on request
- Your client relationship stays yours
Service Scope
Medical writing and programming support for CROs
CROs need outsourced work that is accurate and consistent with work produced in-house. We work within your systems and conventions so deliverables match your internal standards.
Quality system
Your quality system
Your SOPs and your sponsor’s, supported by our ISO 9001:2015 process.
Format
Your templates
Your document shells, styles and version control, so no reformatting is needed.
Confidentiality
Confidential
Your client relationship stays with you. We do not name CRO clients.
Our Services
CRO documents and programming we provide
Available per document, per study or as an ongoing arrangement across a portfolio.
Documents and applicable standards
Full Service List
All services available to CROs
Services are grouped by type of work so you can find what you need. Services governed by a different regulation are listed on the relevant industry page.
40 services, grouped
Available individually or together. When several services run at once, one project lead coordinates them so the documents stay consistent.
Who We Serve
Teams we work with at CROs
We support the following functions within contract research organisations.
Who we support
Our compliance and guideline standards
Guidelines and standards we work to
Your sponsor’s standards take priority, with ours applied underneath. Where a standard has changed recently, the deliverable records which version was used.
Applicable standards
Use of AI Tools
AI tools support search and formatting. They are not used to write your scientific content.
This policy applies to every service and every industry, regardless of deadline.
Our AI policy
How it works
Our five-step process, starting with a free assessment
We review your materials before providing a quote.
One
Initial assessment
Two business days, at no cost. We set out what the work requires, who will lead it and the cost.
Two
Named team
We confirm who is assigned and their relevant experience before work starts.
Three
Outline approval
You approve the content and sources for each section before drafting begins.
Four
Draft and review
Independent review, quality control and reference verification, each signed off separately.
Five
Handover
The final deliverable with its working files under version control, revised within the agreed scope.
Throughout
One project lead
One project lead coordinates the work so all documents remain consistent.
Project Inputs
Send us your existing materials and we will identify any gaps.
Many projects start with incomplete material, so the initial assessment includes a review of what is available.
You send
Existing materials
Existing documents, your templates and the required completion date.
We send back
Written assessment
What is available, what is missing and the condition of existing material.
Then
Packages
A quote for the engagement, with the named team and timeline, before you commit.
Our experts
Our CRO writing and programming team
Writers are assigned by subject and industry, not by availability. They hold a master’s degree or doctorate in life sciences, medicine, pharmacy or a related discipline, with at least five years of experience in the field. Keeping up to date with the relevant guidance is part of their regular work.
Specialists involved
Sample work
Example deliverables and methods
Published with client agreement and redacted where requested.
Benefits
Practical benefits for CROs
The benefits clients mention most often.
What you get
Packages
Pricing based on engagement scope
Page count does not reflect the work involved, so we do not price by length. The free initial assessment defines the work and gives you a quote you can budget for.
First
Initial assessment
Free, within two business days. A written assessment of the work required.
Then
A written scope
Deliverables, standards, named team and timeline, agreed before work starts.
Quoted
Per engagement
One price for the agreed scope, with revisions included rather than charged per round.
Quality Assurance
Revisions within the agreed scope
If a deliverable does not meet the scope you approved, we revise it at no additional charge and repeat the independent review.
What is covered
FAQs
Common questions from CROs
Disclosure to your sponsor is your decision. We work under your SOPs and in your templates, and we do not name CRO clients or their sponsors. If your sponsor contract requires subcontractors to be declared, we will provide the qualification records you need.
Usually, depending on your access model. If a document must stay in your eTMF or validated authoring environment, we work within it. If not, we work externally and you import the files, with version control agreed at the start.
The free initial assessment takes two business days and confirms whether your date is achievable. If it cannot be met to the required standard, we tell you at that stage rather than overcommitting.
Yes. For study reports, combining both usually works better, because the writer can check that each table supports the text that cites it.
We use separate teams, no shared working environment and a mutual NDA before any material is exchanged. If a conflict cannot be managed, we decline the second engagement.
We do not conduct studies, monitor sites or operate pharmacovigilance systems. We do not manage your sponsor relationships or approach your clients. We do not audit or certify GCP compliance; that remains with your quality function.
Related services
Related industries and services
If your project spans more than one area, the same team can support it.
Other industries and topics
Discuss your CRO support requirements
The initial assessment is free and takes two business days. You receive a written summary of the work required and who would lead it.