BITE SIZE VALIDATIONS
Method Comparison and Bias Estimation- initial analytical evaluation
Evaluate the test method over the clinically meaningful range, i.e., where medical decisions are made. Analyze at least 40 samples as CLSI EP9-A2 recommendations.
Method Comparison and Bias Estimation- extended clinical evaluation
Structured comparison of a new examination procedure with an existing or comparator method.
Depending on the application, this may include assessment of:
- Bias
- Agreement
- Precision
- Range
- Clinically relevant concentrations
- Statistical performance
Evaluate the test method using 100 clinically meaningful samples against reference methods.
Robustness
Evaluate method stability under varied conditions. Includes solution stability and system suitability parameters.
Minimum of 120 data points used in this study.
Validation support
User requirements and verification plan
We can support the practical design of:
- Precision studies
- Method comparisons
- Linearity studies
- Interference studies
- Analytical specificity studies
- Clinical performance studies
- Reproducibility studies
- Other method-specific evaluations
Prices are dependent of study size and complexity of requirements
Our approach
01 — Understand
We establish the intended use, clinical application, method characteristics and laboratory requirements.
02 — Design
We develop a validation or verification strategy appropriate to the method, risks and intended use.
03 — Execute
We support with study implementation, clinical samples, testing and data collection.
04 — Analyse
We review the results using appropriate statistical and scientific approaches.
05 — Document
We produce clear evidence and conclusions that demonstrate whether the method is fit for its intended purpose.
06 — Implement
We help you translate the findings into your laboratory's implementation and quality documentation.
Validation centre
Install your instrument at our London Research site
From early-stage R&D to post-market surveillance, we deliver end-to-end testing solutions and performance evaluations across analytical biomedical testing platforms.