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LABORATORY MEDICINE  IN CLINICAL TRIALS

We provide comprehensive support in laboratory, molecular, and pathomorphological testing for clinical trials of medicinal products, medical devices, and IVD tests at all stages

– from planning to the final report.

We combine diagnostic expertise with scientific and regulatory practice.
We fully understand that every project requires an individual approach, which is why you can rely on our professional, tailored solutions and consultation services to addres the specific needs of your research.


Our laboratories operate under quality systems such as:


ISO 15189   |   Good Laboratory Practice   |   ISO 9001   |   ISO 27001   |   ISO 14001

Diagnostic areas in which we conduct tests include:​

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  • General medical laboratory diagnostics,

  • Microbiology,

  • Genetics,

  • Transfusion serology,

  • Toxicology and clinical pharmacology,

  •  Pathomorphology.

As part of project support, we provide:

 

  • Expert support in preparing grant applications,

  • Expert support in preparing submissions to bioethics committees,

  • Scientific guidance, including identification of appropriate diagnostic methods tailored to clinical   trial or medical experiment requirements,

  • Assistance in designing experiments in accordance with international standards and protocols,       including GCP, GLP, OECD, REACH, CIPAC, ISO, GoRENI, INHAND,

  • Provision of sample collection kits,

  • Protocols detailing sample collection and preservation procedures,

  • Logistics support (sample collection and transport),

  • Sample preservation and banking,

  • Statistical analysis and visualization of research results,

  • Preparation of photographic documentation, including analysis,

  • Assistance in preparing reports and publications (methodology descriptions, results, figure     preparation).

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