Clinical studies
Currently, JSC K+31 is at the stage of obtaining registration
for inclusion in the list of medical organizations entitled
to conduct clinical trials of medical products within
the Eurasian Economic Community.
for inclusion in the list of medical organizations entitled
to conduct clinical trials of medical products within
the Eurasian Economic Community.
Clinical trials in K+31 are:
- Full compliance with standards
- Support for each stage of registration of a medical device/drug
- Highly qualified personnel with experience in clinical trials
- A wide range of clinical trials
- Experience working with commercial and government customers
- Clinical trials of any complexity
Some examples of successful clinical trials based on K+31:
- Immunotherapy in the first line of metastatic (stage IVB) or recurrent (after radical treatment) cervical cancer.
- Analysis for IgG antibodies (spike S1 protein) to the SARS-CoV-2 virus in blood serum by the enhanced chemiluminescence method.
- A set of reagents for the extraction of RNA from clinical samples.
- Analysis for the qualitative immunochromatographic detection of viral antigens SARS-CoV-2, Influenza A and Influenza B.
- Clinical trial of a new drug - intranasal vaccine compared to Gam-COVID-Vac vaccine in healthy volunteers.
K+31 Clinics are included in the list of medical organizations conducting clinical trials of medical devices (No. 1416 of the RF Government Resolution): "List of medical organizations conducting clinical trials of medical devices."
The cost and timing of the tests depend on the purpose and complexity of the medical device and are agreed upon individually.
For additional information:
Temirkan Aslanovich Khunagov t.hunagov@k31.ru
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