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IVD Performance Evaluation, Statistics and Diagnostic Publications
Pubrica supports in vitro diagnostic manufacturers with performance evaluation documentation, statistical analysis and scientific publications. We prepare IVDR performance evaluation plans and reports, scientific validity reports, diagnostic accuracy studies reported under STARD and prediction model reports under TRIPOD+AI. Reports present predictive values at the claimed prevalence alongside sensitivity and specificity, and state the limits of retrospective model validation.
Predictive values are reported with the prevalence they depend on.
- Current IVDR requirements
- Predictive values reported in context
- Your QMS and templates
- Mutual NDA on request
- You remain the manufacturer
Service Scope
IVD performance evaluation and diagnostic accuracy reporting
Sensitivity and specificity describe the test. Predictive values show what a result means for the patient, and they change with prevalence. We report both so performance data reflects the intended clinical setting.
Reporting
Accuracy in context
Sensitivity, specificity and the predictive values at the prevalence you are claiming for.
Audience
A notified body reviewer
Under IVDR, scientific validity, analytical performance and clinical performance are addressed separately.
Validation
Prospective evidence where needed
Models that perform well on retrospective data often do not hold prospectively, and we report this clearly.
Our Services
IVD documentation and publications we prepare
Available as individual documents or as a full file. We also work on evaluations that have previously been rejected.
Documents and applicable standards
Full Service List
All services available for diagnostics
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.
44 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 diagnostics companies
We support the following functions within IVD manufacturers.
Who we support
Our compliance and guideline standards
Guidelines and standards we work to
Each standard is applied at its current edition, with the date it was checked. 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 evaluation, with the named team and timeline, before you commit.
Our experts
Our diagnostics writing and statistics 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 diagnostics programmes
The benefits clients mention most often.
What you get
Packages
Pricing based on evaluation 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 evaluation
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 about diagnostics work
They are different regulations with different document sets. MDR requires clinical evaluation. IVDR requires performance evaluation built from three strands: scientific validity, analytical performance and clinical performance. Treating one as the other is the most common structural error we see, and reviewers notice it quickly.
Usually not. Retrospective performance on curated data is limited evidence for prospective use, especially when the training and test sets share a source. TRIPOD+AI requires reporting of the factors that reveal this, and we include them in the report.
Either. A statistician can run the ROC analysis, sample size calculation and method comparison, or review your existing analysis and identify points a reviewer is likely to question.
Yes. A companion diagnostic must meet IVDR requirements and support the medicine’s labelling, so we recommend one project lead across both. The initial assessment will set this out.
Yes. Auditors assess your templates, so we work within them, supported by our ISO 9001:2015 certified process.
We are not a notified body and do not certify products. We do not run performance studies or operate post-market performance follow-up. We write the plans and reports; surveillance runs under your QMS. You remain the manufacturer throughout.
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 diagnostics or IVD project 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.