Since 2015, we have been conducting late-phase clinical trials at our organisation's clinical sites. More than 40 investigators are involved in late-phase clinical trials.
WE CONDUCT LATE-PHASE CLINICAL TRIALS IN THE FOLLOWING MEDICAL SPECIALTIES:
Obstetrics and gynecology
Allergology and immunology
Gastroenterology
Hematology
Dermatology
Immunoprophylaxis
Infectious diseases
Cardiology
Neurology
Oncology
Otolaryngology
Psychiatry
Pulmonology
Rheumatology
Vascular Surgery
Cosmetology
Therapy
Traumatology and orthopedics
Urology
General surgery
Endocrinology
Clinical trials of drugs for the treatment of inflammatory bowel diseases (Crohn’s disease and ulcerative colitis) have been developed into a separate area of activity with the creation of a Research Centre for Functional and Organic Bowel Diseases.
Recombinant vaccine against novel coronavirus infection based on type 5 adenoviral vector
SUBJECTS:1600(healthy volunteers)
RECRUITMENT DURATION:6weeks
RECRUITMENT DURATION:16months
Peculiarities:This was one of the first clinical trials of a vaccine to prevent infection with the SARS CoV-2 (2019-nCoV) virus. This trial was critical for the rapid pace and volume of subject recruitment against the backdrop of strict epidemic control measures in the midst of the COVID-19 pandemic. The main feature of this trial was the large volume of activities to interact with subjects as part of the evaluation of the efficacy and safety parameters of the study vaccine. The successful implementation of the research task was made possible by the operation of a Unified Call Centre, operating seven days a week, as well as the introduction of our own digital services into the work of the Call Centre.
Humanised monoclonal antibody variant IgG4 against interleukin-23 (IL-23)
SUBJECTS:8(subjects with nonspecific ulcerative colitis)
RECRUITMENT DURATION:6months
RECRUITMENT DURATION:36months
Peculiarities:A phase 3 clinical trial was conducted at the Research Centre for Functional and Organic Bowel Diseases to evaluate the efficacy of a humanised monoclonal antibody variant IgG 4 against IL-23 in patients with active moderate or severe ulcerative colitis. The trial involved a complex endoscopic assessment of the parameters of inflammatory lesions of the colonic mucosa and the processing and sending of biospecimens to the central laboratory for immunological testing. The successful implementation of this project was achieved through the involvement of a research team specialized in this type of nosological form, with experience in more than 25 clinical trials.
Molnupiravir for the etiotropic treatment of SARS-CoV-2 virus infection
SUBJECTS:36(subjects with COVID-19)
RECRUITMENT DURATION:1month
RECRUITMENT DURATION:12months
Peculiarities:one of the first clinical trials to evaluate the efficacy of a drug for etiotropic therapy in patients with SARS-CoV-2 virus infection, conducted at the height of the COVID-19 pandemic. A unique feature of this trial was the need to perform a number of important protocol activities (signing informed consent, obtaining insurance, handling study drug, collecting and transporting biospecimens, etc.) at home under difficult epidemiological conditions. Many aspects of this trial were successfully implemented thanks to the introduction of standard operating procedures in the work of the Research Centre in relation to activities performed at home, as well as the development of a safety data sheet for the activities of a medical organization in the context of the COVID-19 pandemic.
