Scientific Validity Report Writing for IVD Manufacturers
Pubrica writes scientific validity reports for in vitro diagnostic manufacturers preparing performance evaluations under IVDR 2017/746. Scientific validity concerns whether the analyte you measure is associated with the clinical condition you claim, independently of how your assay performs. Notified bodies expect this association to be evidenced systematically. Our IVD performance evaluation writers search and appraise the peer-reviewed literature, clinical guidelines and consensus statements, and deliver a report with a recorded, reproducible search that feeds your performance evaluation report.
- Focused on the analyte, not the device, because the association must hold independently of how well your assay measures it
- Evidenced systematically from peer-reviewed literature, clinical guidelines, consensus statements and proof-of-concept studies
- Transferability to the claimed population, because an association established in symptomatic patients does not automatically apply to screening
- Contrary evidence addressed, because an assessor searching the same literature will find studies that did not support the association
- Written to feed the PER, as one of the three reports the performance evaluation report brings together
Systematic literature basisIncluded
Guidelines and consensus assessedIncluded
Population transferability addressedIncluded
Contrary evidence addressedIncluded
Asserting an association as well knownNot accepted as evidence
Analyte → literature → appraised → population → validity
- Search recorded and reproducible
- Guidelines and consensus weighted
- Population transferability tested
- Contrary evidence addressed
- Written to feed the PER
Deliverables
Four Core Elements of Every Scientific Validity Report
A scientific validity report applies systematic review methods for a regulatory purpose, and it is judged on whether another reviewer can confirm the association.
Example from a scientific validity reportAnalytical performance does not establish scientific validity. A precise measurement of a biomarker with no demonstrated clinical association has no clinical value.
Example from an evidence appraisalThe biomarker is well established in this condition.The association is established in symptomatic adults presenting to secondary care. Evidence in asymptomatic screening populations is limited to two cohort studies, both of which report a weaker association. The claimed intended purpose includes screening.
Example from a guideline reviewA guideline that mentions the analyte is different from a guideline that recommends it. The report states which applies, because the assessor will read the guideline.
Example from a method sectionAn assessor who runs the same search will find the same studies. A report that omits them puts its own method in question.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Regulatory and Methodological Standards for Scientific Validity Reports
A regulatory report prepared using systematic review methods.
In Vitro Diagnostic Regulation (Annex XIII)
Sets out performance evaluation on three pillars, scientific validity, analytical performance and clinical performance, each evidenced separately and each feeding the performance evaluation report.
PRISMA 2020 (literature methodology)
Sets out the search and screening methods that underpin a defensible clinical or performance evaluation, so that an assessor can reproduce your literature review.
Clinical evaluation guidance (June 2016)
The structure notified bodies still assess against, read alongside MDCG 2020-13, which is the assessment template assessors use.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our quality management system governs how each project is run, recorded and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a named individual. For this reason, source traceability takes priority over speed in our regulatory writing, and every statement must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our Scientific Validity Report Writing Process Works
We define the claimed population first, because the association must be shown to hold in that population.
Claimed Purpose and Population Definition
We define the analyte, the clinical condition and the claimed population precisely from the intended purpose.
Systematic Evidence Search
We search the literature, guidelines and consensus sources systematically and record the strategy for each source so that it can be rerun.
Evidence Appraisal and Transferability Assessment
We assess study quality, weight the evidence and test transferability to the claimed population explicitly.
Report Writing
We write up the findings, address contrary evidence and state the conclusion at the strength the evidence supports.
Our Experts
Your Scientific Validity Report Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
Scientific Validity Report Service Packages
Pricing depends on how established the analyte is. A well-known association mainly requires literature assembly, while a novel one requires a full review.
Scientific validity report
For one analyte and one claimed purpose
Quoted per projectBased on analyte novelty and literature volume
Delivery By scope
- ✓Search recorded per source
- ✓Literature, guidelines and consensus appraised
- ✓Population transferability tested
- ✓Contrary evidence addressed
- ✓Conclusion stated at supportable strength
- ✓Written to feed the PER
Tell us the claimed population. Screening claims carry a substantially higher evidence burden than claims for symptomatic patients.
Deliverables Request a quoteComplete Performance Evaluation: All Three Pillars
For the complete performance evaluation
Quoted per projectBased on class and evidence available
Delivery By scope
- ✓Scientific validity report
- ✓Analytical performance report
- ✓Clinical performance report
- ✓Performance evaluation report assembling all three
- ✓Consistency checked across the package
The PER is assessed as one document, and reports written separately often contain small inconsistencies, so we check consistency across the package.
Deliverables Request a quoteScientific Validity Report Update
For an existing report
Quoted per projectBased on elapsed time and new evidence
Delivery By scope
- ✓Search rerun against the recorded strategy
- ✓New evidence appraised and added
- ✓Guideline changes tracked
- ✓Conclusion revised where the evidence moved
- ✓PER impact assessed
An update is possible only where the original search was recorded. Otherwise, a new report is required.
Deliverables Request a quoteSend the analyte and the claimed intended purpose, and we will scope the evidence position at no cost, including whether the literature supports your claimed population.
FAQs
Scientific Validity Report FAQs
If your question is not answered here, ask an expert. No quote is required.
Yes. IVDR requires scientific validity to be demonstrated, and describing an analyte as well established is an assertion rather than a demonstration.
For an established analyte, the report is mainly literature assembly and is not costly. Omitting it entirely is what leads to a finding.
They can contribute, but scientific validity concerns the analyte-condition association independently of your assay, so external evidence carries more weight.
For a novel analyte, your own proof-of-concept and clinical work may be the main evidence, and the report must state this explicitly.
The report states the limitation, and either the intended purpose is narrowed or the gap is assigned to post-market performance follow-up.
Claiming a population that the evidence does not support is likely to fail at assessment, often late in the process.
No. Scientific validity asks whether the analyte relates to the condition. Clinical performance asks whether your assay’s result performs clinically — sensitivity, specificity, predictive values.
A test can have strong scientific validity and poor clinical performance, but not the reverse, which is why scientific validity is established first.
Related Services
Related Regulatory Writing Services
Scientific validity is one of the three pillars of performance evaluation, and the other two depend on it.
1OTHER PERFORMANCE EVALUATION REPORTSsame package
Performance evaluation planPlans all three reports. Performance evaluation reportBrings the three reports together.2METHODOLOGYsystematic review methods
Systematic reviewThe search and appraisal method. State-of-the-art reviewThe benchmark for the indication.3OTHER TECHNICAL FILE DOCUMENTSalongside
Device risk managementISO 14971 risk management file. PMS and device PSURPost-market surveillance after placing on the market.Request a Free Evidence Scoping for Your Analyte and Claimed Purpose
We will confirm whether the literature supports your claimed population.