We believe IVDR drives the need for performance studies and market surveillance studies in a clinical laboratory setting. We believe better products can be developed if creators of future IVDs get early feedback from end-users and lean access to clinical samples.

Our customers:

  • In-vitro diagnostics industry (IVD)
  • Contract research organization (CRO)
  • Research institutions (RUO testing)
  • Pharmaceutical industry
  • Life science companies

 

  • Our offerings
    • Study implementation in a variable testing environments (core lab, satellite lab, POCT setting)
    • Study design support
    • Compilation of IRB application, contact point for all queries for the IRB
    • Co-development of new biomarkers with industrial collaboration partners
    • Reference method development
    • Performance study services in a clinical laboratory setting
    • Bio statistical analysis
    • Result presentations

    • Dedicated project leaders, research scientists and technicians for your project
    • Dedicated lab space with different levels of confidentiality
    • Recruitment of healthy volunteer and patient groups
    • Full spectrum of laboratory diagnostics across 9 diagnostic fields
    • Compliance with the current quality specifications
    • ISO 20916 compliant study environment
    • ISO 15189 accredited laboratory

Common types of studies and collaborations

Who we are

Klaus Tenning
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Leiter Studien und Kooperationen

Tel.: +49 (30) 40 50 26-800

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Dr. Kolja Hegel
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Projektleiter

Tel.: +49 (30) 40 50 26-800

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Labor Berlin – Charité Vivantes GmbH
Tel: +49 (30) 405 026-800

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