WHY US

IVD TRIALS –
your European specialist for clinical IVD studies

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What sets us apart

We understand the unique requirements of your project. This is why we will provide you with exceptional support and resources.

Unlike many other CROs, we offer true full service:
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  • Direct sample access through own collection sites, a worldwide samples network and the BIOMEX human biospecimens inventory. Sourcing of clinical samples like dengue or chikungunya samples from newly infected patients, all HIV subtypes, or progression samples from Lyme disease patients.
  • Large L2 and L3** lab facilities to work with specific risk group 3 pathogens such as HIV or SARS-CoV-2.
  • 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, ISO 14155 and ISO 17025 (certification in progress).

Why we are the right partner for your successful IVD study

From development to post-market: What sets us apart from the competition is our unique study “system”: instead of relying only on freelancers and external collection sites, we run your clinical trial with nearly 100% of our own staff! This includes our own donation centers, internal lab facilities, regulatory department, warehousing and logicist – so your IVD study becomes not a nightmare, but a true success story!

Direct access to human biospecimens

As part of the German MEX Group, only IVD TRIALS can offer you fresh collections in our own donor centers and partner sites, as well as direct access to more than 900,000 human samples in stock. This includes all kinds of human biological specimens and matched sets, from healthy donors or diseased patients.

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Why to trust IVD TRIALS

    There are many CROs. Only very few focus 100% on IVDs, like IVD TRIALS. We take pride in being the trusted supplier to numerous companies.
    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.
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