Types of Evaluations
User define Evaluations
Method validation / verification is undertaken against a defined protocol / study plan, pre-approved & tailored to be stage appropriate for the development by the customer.
Our team undertake the entire validation process and publish in reputable journals to showcase your device/assay's performance and specifications as required.
Performance Evaluation (PQ)
We undertake a systematic approach to investigations that begins with pre-defined objectives based on extensive clinical input, sound science and quality risk management. Investigations provided:
- Reproducibility & Accuracy
- Analytical Specificity
- Identify Interferences; i.e. concurrent drugs
- Est. Normal range
- Linearity analysis
- Method Comparison
- Standard operating manual construct
- Validation document written up for clinical sign off
Comparative Testing
Use one of our collaborating laboratories for method specific comparison using same batch of materials
(i.e. samples are analysed by the receiving laboratory in accordance with the test method, and the results are compared with the results obtained by the originating site for the same batches.
The results obtained from both sites are demonstrated to be comparable, against pre-defined acceptance criteria).
Device Optimisation
Improve performance with validations designed detect assay limitations, find solutions, improve sensitivity and specificity on chosen disease states.
Evaluation across different sites
Multisite evaluations using a range of platforms to examine variability and procedural non conformities.
Clinical Evaluation
Our Service evaluation are clinically lead.
We perform retrospective and or prospective studies and have access to a wide range of samples and pathologies.
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.
Guide for individual evaluation types and Part number
Full Assay validation-Part Number 180101
Bringing inhouse products to clinical use using relevant essential requirements of the IVD Directive 98/79 EC or Regulation 2017/746
Phase 1: Feasibility
Minimum data point analyzed: 100 samples
- Clinical application research
- Establishment of intended use
- Scope utility: comparison to other methods
- Validate Specificity claims
- Initial Quality program design
- Product application sheet construct
- Feasibility data publication
- Validation action plan write up
Phase 2: Design qualification
Minimum data point analyzed: 100 samples
- Assay optimization plan
- Establishment of best practice. Pre-analytical, sample types, sample stability, sample rejection criteria
- Instrument maintenance / critical operational elements identification
- Identify reagent best practice; reagent source, stabilities
- Finalize Quality program/SOP
- Estimation of margin of error (MU)
Phase 3: Performance Qualification
Minimum data point analyzed: 200 samples
Clinical verification
- Reproducibility & Accuracy
- Analytical Specificity
- Identify Interferences; i.e. concurrent drugs
- Establish Normal range
- Linearity analysis
- Method Comparison
- Standard operating manual construct
- Validation document written up for clinical sign off
bite size validations
Method Comparison and Bias Estimation- initial analytical evaluation
Part number:1503
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
Part number:1504
Evaluate the test method using 100 clinically meaningful samples against reference methods and perform data analysis and clinical correlation
Robustness
Part number:1505
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
Part number:1506
Design verification documentation to confirm that the design output meets the design input requirements.
Sample requirements
Part number:1507
Identifying sample requirements as per verification plan and sourcing them for the study.
Prices are dependent of study size and complexity of requirements