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IVD TRIALS – Your German partner for high-quality trials!
With our expert team and numerous test systems in house, we perform the entire validation process for you at our own facilities.

Take advantage of our extensive know-how in analytical and clinical validations, compliant with the European IVDR, Chinese NMPA, Australian TGA or WHO regulations.

Your advantages:
IVD professionals at your service
Highest quality at a reasonable price
Best chances for an approval of your assay

Performance evaluation for In vitro Diagnostics (IVD)
As a renowned regulatory expert and contract research organization (CRO), we provide professional support at every step of your performance evaluation.

Analytical performance studies:
Under IVDR, for example, we offer all analytical performance testing relevant of Annex I parameters such as analytical sensitivity, analytical specificity, trueness, precision, and accuracy.

Clinical performance studies:
Use our services to test all IVDR Annex I parameters, such as diagnostic sensitivity, diagnostic specificity, positive and negative predictive value, likelihood ratio, and expected values in normal and affected populations.

What sets us apart
Your study is unique – even if it follows specific guidelines.
Our infrastructure is unique – which is why we can offer you services like no other IVD CRO.

Our services:
Daily prospective collections in own donation centers
Large L2 and L3** lab facilities
Direct access to Europe’s largest commercial inventory of human biospecimens via our sister company BIOMEX
Study design at the highest quality levels
External quality assurance according to DIN EN ISO/IEC 17025