HAEMOSTASIS REASEARCH UNIT
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    • Home
    • Services
      • Accreditation Services
      • Validation Services
      • Product Development
      • PT/EQA program
      • Training services
      • Online Ordering
    • about us
    • Further information
      • Regulation updates
      • Case Studies
      • Adverts
      • Testimonials
      • Blog
      • Terms and Conditions
      • Privacy Policy
HAEMOSTASIS REASEARCH UNIT

Signed in as:

filler@godaddy.com

  • Home
  • Services
    • Accreditation Services
    • Validation Services
    • Product Development
    • PT/EQA program
    • Training services
    • Online Ordering
  • about us
  • Further information
    • Regulation updates
    • Case Studies
    • Adverts
    • Testimonials
    • Blog
    • Terms and Conditions
    • Privacy Policy

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Welcome to the Implementation and Validation team

Find out more

Validation work for manufacturers

Implementation support

Working with your install teams we will complete the analyser verification to ensure your client can go live with services as soon as possible and hassle free.  

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. 

IVD development evaluations

Assay Validation

Our team can undertake  the validations of all haemostasis testing including research only assays.

Instrument Optimisation

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

Device Feasibility studies

We have a range sample types  for clinical feasibility studies using prospective and retrospect study models to identify intended use or widen assay utility.

Adjusting formulation

Identifying interferences and adjusting protocols to improve specific and sensitivity  

Innovative solutions are transforming diagnostics in the medical field, ensuring accuracy and compliance like never before. Embrace the future of healthcare with our transitional validations  designed to enhance laboratory efficiency and patient outcomes.

Find out more

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 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 

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 undertake  the entire  validation process and publish in reputable journals  to showcase your device/assay's performance and specifications as required. 

Get a quote

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.

Get a quote

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 demonstrated to be comparable, against pre-defined acceptance criteria).

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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.   

Get a quote

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.

Get a quote

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.

Get a quote
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