Welcome to ISOCHECKS Diagnostic Solutions
Biomedical Assay Development and Validation Services
To support transition of diagnostic innovations and Laboratory Developed Tests toward clinical use
To support transition of diagnostic innovations and Laboratory Developed Tests toward clinical use
ISOCHECKS Diagnostic Solutions partners with In Vitro Diagnostics (IVD) manufacturers & developers, clinical research organizations and clinical laboratories to provide an efficient user defined validations, optimization and feasibility studies to achieve accurate and reliable diagnostic results.
With a dedicated Research and Innovations site located at central London, specializing in Haemostasis and blood sciences to support new diagnostics to the market, optimize diagnostic processes and progress research and development for the clinical diagnostics industry.
We are a clinically run company incorporating the full ranges of diagnostic professionals so whether you require early feasibility studies to full analytical and clinical validations please get in touch and see how we can collaborate to change the future of clinical diagnostics.
Service evaluations for diagnostic development
Method Comparison and Bias Estimation
Defining clinical intended use of the IVD
Compliance for Laboratory developed tests
Skills to meet the evolving medical field demands
Production of Calibrators & Quality Control
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 consultants and supported by PHD specialists 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.
We routinely cover services throughout UK and Europe. Slowly we growing in to other countries so we would love to hear from you no matter where you are located.