We undertake a systematic approach to investigations that begins with pre-defined objectives based on extensive clinical input, sound science and quality risk management.
Our work is always lead by clinical consultant and supported by PHD specialist in the field to ensure clinical and scientific input is at the highest specification.
We use a range of Biomedical scientist also to ensure the evaluation represents real life experience of the product
We have access to range sample types in our biobank and a number of collaborating clinical laboratory sites to ensure evaluations undertaken can be as extensive as required.
We have the capacity to install devises onsite, perform studies at a collaborating site or provide a full validation sample packs to undertaken local validations.
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 can undertake the validation and publish in reputable journals to showcase your device/assay's performance and specifications as required
Method validation / verification is undertaken against a defined protocol / study plan, pre-approved & tailored to be stage appropriate for the development by the customer.
We undertake a systematic approach to investigations that begins with pre-defined objectives based on extensive clinical input, sound science and quality risk management.
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 demo
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).
Improve performance with validations designed detect assay limitations, find solutions, improve sensitivity and specificity on chosen disease states.
Multisite evaluations using a range of platforms to examine variability and procedural non conformities
Our Service evaluation are clinically lead.
We perform retrospective and or prospective studies and have access to a wide range of samples and pathologies.
ISOChecks.co.uk