Late phases

From exploratory to pivotal research in most fields of medicine
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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.

AN IMPORTANT ACTIVITY IS CLINICAL VACCINE TRIALS.
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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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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.

        CONTACTS US

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          About us

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          Contact us

          196143, St. Petersburg,
          Yu. Gagarin Ave., 65.
          Metro station “Zvezdnaya”, “Moskovskaya”
          Tel.: +7 (812) 500-52-03
          nic@ecosafety.ru

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