What sets us apart

What sets us apart

We understand the unique demands and the complexity of your projects, and that’s why we go the extra mile to provide you with exceptional support and resources.

Unlike many other CROs, we offer a full service:

  • Own donation centers for prospective collections with hundreds of donors to source samples precisely for your study

  • Large L2 and L3** lab facilities that allow us to work with specific risk group 3 pathogens such as SARS-CoV-2 or HIV

  • Europe's largest commercial inventory of human biospecimens and a worldwide network that enables us to source a wide range of clinical samples, such as dengue or chikungunya samples from newly infected patients, all HIV subtypes, or progression samples from Lyme disease patients

  • Study design, ethics approval, study performance, data analysis, and the final report, all included at the highest quality levels

  • A quality management system that is accredited to ISO 9001 – all studies are performed in accordance with ISO 20916:2019 and ISO 14155; currently, we are working on obtaining ISO 17025 certification for our laboratories

Your success is our priority, and we’re here to support you every step of the way. You would like to get more background information?

Please check out our FAQ page or contact us. 

Why to trust BIOMEX

We have successfully conducted hundreds of studies, not only according to European specifications, but also, for example, according to Chinese (NMPA), Australian (TGA) or to the specifications of the World Health Organization (WHO).

The validated assays include numerous indications and analytes, such as HIV, HPV, HCV, HBV, HAV, SARS-CoV-2, syphilis, hemoglobin, bilirubin, urobilinogen, ketone, protein, nitrite, glucose, pH, leukocytes, and ascorbic acid.

For SARS-CoV-2 rapid tests alone, we are the provider that has validated the largest number of assays according to the European IVD Regulation. 

Your Experts for Diagnostic Studies

You want to bring your assay to market as quickly as possible? We can help you with this – with our years of experience in diagnostic assay validation, broad regulatory expertise, large in-house biospecimens inventory, and our own donations centers.

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