Our team can independently evaluate the analytical and clinical performance of diagnostic tests, provide regulatory consultancy and protocol writing.
We can provide independent evaluations and evidence to support regulatory applications and proof of concept data for funding applications. The evidence we provide is often used in CE and UKCA marking of IVDs, as well as submissions to the CDTA and FDA, and to satisfy compliance with MHRA and IVDR.
The technologies we assess are at various stages of development, from early concepts through to devices that are market ready.
All of these diagnostic tests and technologies need testing with appropriate clinical samples and robust evaluation to validate their analytical or clinical performance and to assess usability.
We have already supported the development of diagnostic tests from around the globe.
Protocol development
Our team’s wide range of expertise and specialist skills can assist partners with advice and consultancy regarding protocol and methodology development. Our protocol development service is flexible and can design tailored studies and experiments to meet your evidence requirements.
Analytical performance
Our expert scientists can conduct testing to support analytical performance claims, including limit of detection, linearity, range, repeatability, analytical specificity, analytical sensitivity and robustness.
Clinical performance evaluation
We are able to collect bespoke clinical samples from patients in our hospitals, which have been carefully selected into representative cohorts to assess the performance of diagnostics, as well as the provision of appropriate reference standard testing.
Control materials
Our team can advise on and select appropriate contrived, control and reference materials sourced from a number of suppliers for your assay
Watch our video and read our case studies.
For more information or if you would like to work with us please contact us.
