Late phases

LATE-PHASE CLINICAL TRIALS

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.

AN IMPORTANT ACTIVITY IS CLINICAL VACCINE TRIALS.

Over the past three years, we have conducted more than 20 clinical trials of vaccines to prevent infectious diseases such as Ebola, Marburg, COVID-19, influenza, tuberculosis, hepatitis A, Middle East respiratory syndrome, respiratory syncytial virus infection and human papillomavirus. These trials involved more than 10,000 people.

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ON CENTRE-BASED RESEARCH

THE CENTRE'S CLINICAL FACILITIES

4 outpatient clinics

3 inpatient units with 70 beds

2 intensive care units

Clinical diagnostic laboratory

Functional diagnostics department

Radiological Diagnostics Department

Endoscopy department

Company medical units and health centers in St. Petersburg and Leningrad region (>10)

FUNCTIONAL RESEARCH CENTRES

The Research Centre for Functional and Organic Bowel Diseases

The Research Centre for Early Diagnosis and Treatment of Cancer

The Cosmetology and Plastic Surgery Centre

The Centre for Registration of Medical Devices

EXPERIENCE

To date, we have conducted more than 220 late phase clinical trials. In total, more than 20,000 people have been involved in these clinical trials.

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ON CENTRE-BASED RESEARCH

SERVICE PACKAGE

Recombinant vaccine against novel coronavirus infection based on type 5 adenoviral vector

SUBJECTS: 1600 (healthy volunteers)

RECRUITMENT DURATION: 6 weeks

RECRUITMENT DURATION: 16 months

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.

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Humanised monoclonal antibody variant IgG4 against interleukin-23 (IL-23)

SUBJECTS: 8 (subjects with nonspecific ulcerative colitis)

RECRUITMENT DURATION: 6 months

RECRUITMENT DURATION: 36 months

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.

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Molnupiravir for the etiotropic treatment of SARS-CoV-2 virus infection

SUBJECTS: 36 (subjects with COVID-19)

RECRUITMENT DURATION: 1 month

RECRUITMENT DURATION: 12 months

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.

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WHY IT PAYS TO WORK WITH QBIO

EXPERIENCED RESEARCH TEAM

> 25 principal investigators >50 co-investigators 25 nurses 5 coordinators

OWN PATIENT BASE

Own patient base (over 100,000 people)

EXPERIENCED RESEARCH TEAMS

Availability of research teams specialized in nosological forms

LARGE BASE OF PHYSICIANS AND MEDICAL ORGANISATIONS

Urban referral base
>100 referring doctors in
30 city clinics
10 city hospitals
20 private medical centers

FAST SUBJECT RECRUITMENT

with different nosological forms

FAST AND EFFICIENT COMMUNICATION

with clients through the use of our own digital services for the management of clinical trials

HIGH DATA QUALITY

and quick data entry in the eCRF (Electronic Case Report Form)

TIME AND DEADLINES

Short project completion times

REGULATORY COMPLIANCE

Compliance of all processes with Russian and international regulatory authorities.

Late phases

LATE-PHASE CLINICAL TRIALS

WE CONDUCT LATE-PHASE CLINICAL TRIALS IN THE FOLLOWING MEDICAL SPECIALTIES:

AN IMPORTANT ACTIVITY IS CLINICAL VACCINE TRIALS.

THE CENTRE'S CLINICAL FACILITIES

FUNCTIONAL RESEARCH CENTRES

EXPERIENCE

SERVICE PACKAGE

Recombinant vaccine against novel coronavirus infection based on type 5 adenoviral vector

SERVICE PACKAGE

Humanised monoclonal antibody variant IgG4 against interleukin-23 (IL-23)

SERVICE PACKAGE

Molnupiravir for the etiotropic treatment of SARS-CoV-2 virus infection

SERVICE PACKAGE

WHY IT PAYS TO WORK WITH QBIO

EXPERIENCED RESEARCH TEAM

OWN PATIENT BASE

EXPERIENCED RESEARCH TEAMS

LARGE BASE OF PHYSICIANS AND MEDICAL ORGANISATIONS

FAST SUBJECT RECRUITMENT

FAST AND EFFICIENT COMMUNICATION

HIGH DATA QUALITY

TIME AND DEADLINES

REGULATORY COMPLIANCE

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