Early phases

EARLY PHASE CLINICAL TRIALS

Since its inception, QBIO has specialized in conducting early phase studies in both healthy volunteers and patients with various clinical entities.

We offer services for the organization and conduct of phase 1 clinical trials based on the Pharmacokinetic and Pharmacodynamic Research Centre, which brings together medical departments, a chemical analysis laboratory, scientific and biostatistical groups.

IT IS POSSIBLE TO CONDUCT DIFFERENT TYPES OF PHASE 1 CLINICAL TRIALS:

In healthy volunteers with PK*, PD** and immunogenicity studies

In patients with different nosological forms

In special populations

Using non-standard laboratory and analytical techniques

PK and PD studies of insulins using the euglycaemic hyperinsulinemic clamp method;

Investigation of immunobiological compounds.

* PK – pharmacokinetics
**PD – pharmacodynamics

THE BASE OF THE PHARMACOKINETIC AND PHARMACODYNAMIC RESEARCH CENTRE CONTAINS:

3 inpatient units with 70 beds

2 intensive care units

Chemical analytical laboratory

On-site clinical diagnostic laboratory

2 clinical trials units

Research Department

EVIDENCE-BASED MEDICINE IS BASED ON EXPERIENCE

To date, we have conducted 53 phase 1 clinical trials.

In total, more than 3,000 people have been involved in these trials.

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ON CENTRE-BASED RESEARCH

SERVICE PACKAGE

Vaccine to prevent filovirus infections

SUBJECTS: 50 (Vaccine to prevent filovirus infections)

RECRUITMENT DURATION: 1 month

RECRUITMENT DURATION: 6 months

Peculiarities: During the vaccine clinical trial for the prevention of Ebola virus disease and Marburg haemorrhagic fever, various indicators of cellular and humoral immunity were studied, as well as immunogenicity parameters, which required special conditions for the processing and transport of biospecimens. Strict control of safety parameters with round-the-clock operation of the intensive care unit was also important. The successful resolution of these issues was due to the operation of a unified service for the circulation of biospecimens on the basis of the Centre, with standard operating procedures implemented in practice.

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HUMANISED MONOCLONAL ANTIBODIES AGAINST HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR (HER 2)

SUBJECTS: 84 (healthy volunteers)

RECRUITMENT DURATION: 6 months

RECRUITMENT DURATION: 7 months

Peculiarities: This clinical trial emphasized individual calculation of study drug doses and required a strict dosing regimen using infusion pumps. The study also included very long-term sampling of PK points to investigate pharmacokinetic and immunogenicity parameters. The successful resolution of study drug dosing issues was achieved thanks to the presence of a study drug distribution service at the Centre with implemented standard operating procedures and extensive practical experience in the study of various monoclonal antibodies.

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VECTOR VACCINE FOR PREVENTION OF MIDDLE EASTERN RESPIRATORY SYNDROME

SUBJECTS: 181 (healthy volunteers)

RECRUITMENT DURATION: 4 months

RECRUITMENT DURATION: 12 months

Peculiarities: This study was critical to the rapid recruitment of subjects amidst a high volume of complex protocol procedures. We enrolled 181 subjects over a period of 4 weeks. The successful implementation of this task was made possible by the existence of our own database of over 15,000 healthy volunteers and the introduction of our own digital clinical trial management services into the Centre's operations.

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WHY IT PAYS TO WORK WITH QBIO

EXPERIENCED RESEARCH TEAM

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

EXTENSIVE DATABASE OF HEALTHY VOLUNTEERS

More than 15,000 people in the database

FAST SUBJECT RECRUITMENT

And the possibility of hospitalization in large cohorts (70 persons)

AVAILABILITY OF ANALYTICAL STUDIES

Ability to perform analytical studies using non-standard methods

TURNKEY PROJECT OPPORTUNITY

From study design and protocol writing to final report preparation

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.

MEDICAL LICENCES

for > 35 medical specialties and for carrying out activities related to the circulation of narcotics, psychotropic substances and their precursors

Early phases

EARLY PHASE CLINICAL TRIALS

IT IS POSSIBLE TO CONDUCT DIFFERENT TYPES OF PHASE 1 CLINICAL TRIALS:

THE BASE OF THE PHARMACOKINETIC AND PHARMACODYNAMIC RESEARCH CENTRE CONTAINS:

EVIDENCE-BASED MEDICINE IS BASED ON EXPERIENCE

SERVICE PACKAGE

Vaccine to prevent filovirus infections

SERVICE PACKAGE

HUMANISED MONOCLONAL ANTIBODIES AGAINST HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR (HER 2)

SERVICE PACKAGE

VECTOR VACCINE FOR PREVENTION OF MIDDLE EASTERN RESPIRATORY SYNDROME

SERVICE PACKAGE

WHY IT PAYS TO WORK WITH QBIO

EXPERIENCED RESEARCH TEAM

EXTENSIVE DATABASE OF HEALTHY VOLUNTEERS

FAST SUBJECT RECRUITMENT

AVAILABILITY OF ANALYTICAL STUDIES

TURNKEY PROJECT OPPORTUNITY

FAST AND EFFICIENT COMMUNICATION

HIGH DATA QUALITY

TIME AND DEADLINES

REGULATORY COMPLIANCE

MEDICAL LICENCES

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