Clinical studies
K+31 clinics are included in the list of medical organizations conducting clinical trials of medical devices (No. 1416 RF PP): "List of medical organizations conducting clinical trials of medical devices".
Currently JSC "K+31" is at the stage of obtaining registration for inclusion in the list of medical organizations that have the right to conduct clinical trials of medical devices within the EurAsEC.
Clinical trials at K+31 are:
- Full standards compliance.
- Support at each stage of registration of a medical device / drug.
- Highly qualified staff with experience in clinical trials.
- Large range of ongoing clinical trials.
- Experience working with commercial and government clients.
- Clinical trials of any complexity.
Some examples of successful clinical trials based on K+31:
- Immunotherapy in the first line of metastatic disease (stage IVB) or recurrent (after radical treatment) cervical cancer.
- IgG antibody test ( spike S1 protein) to the SARS-CoV-2 virus in blood serum by enhanced chemiluminescence.
- Reagent kit for RNA isolation from clinical samples.
- Assay for qualitative immunochromatographic detection of antigens of SARS-CoV-2, Influenza A and Influenza B viruses.
- Clinical study of a new drug - intranasal vaccine compared with the Gam-COVID-Vak vaccine in healthy volunteers.
The cost and terms of testing depend on the purpose and complexity of the medical device and are agreed on an individual basis.
For more information:
Khunagov Temirkan Aslanovich t.hunagov@k31.ru
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