Start-up and clinical conduct
Contract, ethics review and site initiation. Screening, inpatient stays, dosing, sample collection and processing, and medical supervision of volunteers.
Bioequivalence · healthy volunteers
Bioequivalence unit (Russia)
We welcome bioequivalence studies involving healthy volunteers at Cytokine's own centre in Pyatigorsk, Russia. Our team provides clinical conduct, monitoring, data management, statistical analysis and reporting under one contract. The client provides the protocol and Ministry of Health authorisation for the study.
Services
From organising clinical conduct to delivering the report and study file to the client.
Samples and monitoring
Sample storage at −70 °C and shipment to the laboratory. Study monitoring, documentation review and checks of protocol compliance.
Data and biostatistics
Data management: case report forms, queries and database lock. Calculation of pharmacokinetic parameters and 90% confidence intervals.
Report and study file
Preparation of the clinical study report and the agreed documentation package for the client.
Bioanalysis is available as an additional service. We agree the provider, method, timelines and terms during project assessment.
Typical study schedule
2×2 crossover design.
Weeks from study start.
Week
1234567891011
Contract, EC review, initiation: от 0 до 1 недель от старта.
Volunteer screening: от 1 до 2 недель от старта.
Period I: от 2 до 2.5 недель от старта.
Washout period: от 2.5 до 3.5 недель от старта.
Period II: от 3.5 до 4 недель от старта.
Monitoring and data: от 1 до 7.5 недель от старта.
Bioanalysis (optional): от 4 до 7.5 недель от старта.
Statistics and PK analysis: от 7.5 до 8.5 недель от старта.
Clinical study report: от 8.5 до 11 недель от старта.
clinical conductdata and statisticsreportoptional
≈ 11 weeksfrom start to clinical study report
An example for a 2×2 crossover design with a 7-day washout period, Ministry of Health authorisation already obtained and the document package prepared. Week 1 includes ethics committee review, with timing subject to the committee's procedures. Clinical procedures begin after the necessary approvals, once the centre and study drug are ready. The overall timeline depends on the protocol, elimination half-life and availability of bioanalytical results.
About the centre
Cytokine's own centre in Pyatigorsk: a dedicated building with inpatient facilities and its own team, approximately 30 minutes from Mineralnye Vody Airport.
- 30 beds
- for volunteer accommodation
- −70 °C
- biological sample storage
- 1 contract
- clinical conduct, data, statistics and reporting
Inpatient facilities
Wards, rooms for dosing and blood sampling, a sample preparation laboratory, an investigational product pharmacy, dining and rest areas, monitoring rooms and an archive.
Samples and equipment
Refrigerated centrifuges, temperature-monitored −70 °C freezers, refrigerators, ECG machines, scales and stadiometers. Equipment maintenance and metrological verification.
Study conditions and safety
Protocol-defined meals and fluid intake, designated areas and access control. Restricted access to study drugs and samples. Emergency medical kits and trained staff.
Volunteer database
Our own database of healthy volunteers, pre-screening and checks for participation in other studies. The investigator assesses eligibility against the protocol.
Team and quality system
Clinical conduct, data management, statistics and reporting within one team.
Investigators and research nurses
Volunteer selection, study procedures and medical supervision.
Clinical research associates
Monitoring study conduct and documentation quality.
Data managers
Case report forms, data queries and preparation for database lock.
Biostatisticians
Pharmacokinetic calculations and statistical analysis.
Medical writers
Preparation of the clinical study report.
Standard Operating Procedures · Internal audit · GCP training
Dosing and each sampling time point are recorded, and deviations are documented. We maintain records in accordance with the protocol and established procedures and prepare them for monitoring, audits and inspections.
Planning a BE study?
Send us your protocol and we will assess timelines, volunteer recruitment and budget.
For healthy volunteers
Current studies for volunteersTaking part in a study
View studies and information on participation. Before enrolment, a doctor assesses eligibility against the protocol.