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HAEMOSTASIS REASEARCH UNIT

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    • Training services
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    • For Manufacturers
    • Haemsotasis Research Unit
    • Controls
    • Products
  • about us
  • Further information
    • Case Studies
    • Testimonials
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Validation work for manufacturers -Why Choose us

Careful planning

 We undertake a systematic approach to investigations  that begins with pre-defined objectives based on extensive clinical input,  sound science and quality risk management. 

Skill mix

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 

Extensive Clinical sample pool

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. 

Flexible

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. 

Types of Evaluations

User define Evaluations

User define 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 can undertake  the validation and publish in reputable journals  to showcase your device/assay's performance and specifications as required 

Performance Evaluation

User define 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.


  We undertake a systematic approach to investigations  that begins with pre-defined objectives based on extensive clinical input,  sound science and quality risk management.

Comparative Testing

User define Evaluations

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 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).

Device Optimisation

Evaluation across different sites

Comparative Testing

 Improve performance with validations designed detect assay limitations, find solutions, improve sensitivity  and specificity  on chosen disease states.   

Evaluation across different sites

Evaluation across different sites

Evaluation across different sites

Multisite evaluations using a range of platforms to examine variability and procedural non conformities 

Clinical Evaluation

Evaluation across different sites

Evaluation across different sites

Our Service evaluation are clinically lead.

 We perform retrospective and or prospective  studies and have access to a wide range of samples and pathologies.

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