Central laboratory (safety and efficacy parameters)
Conducting analysis of biological material of clinical trial subjects for safety and efficacy parameters, including rare diagnostic tests. The clinical diagnostic laboratory is equipped with modern equipment for conducting studies using general clinical, biochemical, immunochemical, coagulation methods, as well as flow cytometry and immunoenzyme analysis.
Provision of a full range of central laboratory services:
Development of an analytical plan and laboratory manual, training of clinical center personnel, project management, logistics services, preparation of visit-specific laboratory kits for collecting biological samples, provision of a database in an agreed format.
9
chromatograph mass spectrometers
that allow for high-precision determination of low-molecular compounds in biological samples
500+
research
on bioequivalence and pharmacokinetics of medicinal products implemented by the laboratory
ISO 9001
Management System
is certified for compliance with the standard of Good Laboratory Practice (GLP) principles
Other services within the scope of the direction clinical studies
01
Pharmacokinetics of small molecules
02
Pharmacokinetics of biotechnological preparations
03
Pharmacodynamics of biotechnological preparations
04
Immunogenicity of biotechnological preparations
05
Statistical processing (BE, I, II, III phases)
06
Comparative Dissolution Kinetics Test (CDK)
07
Biowaiver
08
Preparation of laboratory kits for conducting clinical trials
09
Provision of specific reagents, consumables
See also
Preclinical studies
01
Conducting pharmacokinetic studies on animals
Clinical studies
02
Conducting bioequivalence studies and early phase clinical trials
Pharmaceutical analysis of medicines and dietary supplements
03
Development and validation of regulatory documentation methods: authenticity, quantitative content, dosing homogeneity, impurities, dissolution