Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts

You are here

Central Clinical Trial Laboratory in Russia

Central laboratory was founded in 2007 by leading Russian experts in the field of the laboratory testing.

Services provided:

  • Central laboratory (for samples delivered from any location in Russia)

Standards:

  • European Quality Management System (ISO)
  • We possess all approvals and certificates as required by local and international legislation
  • SOPs
  • According to the German specialist consulting Dr. S. Hake our laboratory is the only laboratory in Russia, which is ready for accreditation with the European organization DAkkS (Deutsche Akkreditierungsstelle) under the international standard ISO 15189:2007

Bioequivalence Studies

Clinical Trial Laboratory
Services provided :

  • Analysis of pharmacokinetics for novel drugs at different phases of clinical trials including phase I
  • Bioequivalence studies of medicinal products in compliance with international standards
  • Investigation of new pharmacokinetic characteristics of registered medicinal products
  • Therapeutic drug monitoring
  • Quality control of medicinal products registered in Russian Federation
  • Detection of fake drugs (independent pharmacological expertise)

  

Our trial laboratory is certified by Federal Agency on Technical Regulation and Metrology of Russian Federation (Rosstandart) (Accreditation certificate No РОСС.RU.0001.21ФЛ13 dated 21.01.2010) according to ISO 17025 standards

Trial Laboratory Equipment

Our Clinical trial laboratory is equipped with the top grade modern analytical equipment of the world's leading manufacturers :

  • Gas chromatography-mass spectrometer 4000 (GC/МS 4000)
  • Liquid chromatography-mass spectrometer 500-MS (HPLC/МS 500-MS)
  • Modular HPLC gradient systems, composed of 2 pumps (ProStar 210), autosampler (ProStar 410), diode-matrix detector (ProStar 335), flowing UV detector for routine analysis (ProStar 335), spectrofluorimetric detector (ProStar 335).
  • Dissolution analyzer VK 7025 (Varian).
  • Dissociation analyzer VK 100 (Varian).
  • In vitro bioavailability analyzer VK 750D (Varian).
  • UV - spectrophotometer Scan 100 (Varian).
  • Infrared Fourier spectrophotometer FTS 1000 (Varian).
  • Water preparation system SG (Germany).
  • Equipment and device for biological probes preparation, centrifuges, pH-meters, refrigerators, freezers etc.
  • production of more than 2000 laboratory tests per day of laboratory tests in all areas of clinical medicine up to 1 day
  • modern methods of express diagnostics ( CITO )
  • 24 hours per day / 7 days per week service
  • team of highly qualified laboratory staff
  • set of advanced equipment and test systems
  • equipment from leading foreign and domestic manufacturers
  • traditional and innovative techniques of laboratory diagnostics
  • compliance with international and national standards of management and laboratory services FindST, GMP, GLP
  • unique laboratory information system ( LIMS )
  • integration into the information system of our partners
  • remote logging of the samples, results available on-line

Laboratory departments

  • Clinical diagnostic laboratory ( KDL )
  • Laboratory of molecular diagnostics ( PCR )
  • Microbiology laboratory
  • Pathoanatomical laboratory
  • Test laboratory ( clinical research )

Laboratory Equipment

Our laboratory is fully equipped with all the necessary equipment of the latest generation from the leading international manufacturers.

  • Immunohemiluminescent automatic analyzer ARCHITECT i2000 (Abbott Diagnostics)
  • Immunohemiluminescent automatic analyzer Immulite 2000 (Siemens)
  • Automatic immunohemiluminescent analyzer Liaison (DiaSorin)
  • Optical aggregometer Aggregometer 490 (Chrono-log Corporation)
  • Automatic biochemical analyzer Advia 1800 (Siemens)
  • Automatic biochemical analyzer Olympus AU 680 (Olympus Diagnostics)
  • Auto Hematology Analyzer CellDyn 3700 SL (Abbott Diagnostics)
  • Automatic biochemical urine analyzer AUTION MAX AX4280 (Arkray)
  • Automatic urine sediment analyzer IQ -200 (Iris)
  • 3 Electrophoresis Systems SAS, SAS 4, SAS 5, (HELENA Bio Science)
  • Automatic system for ELISA BEP 2000 (Dade Behring)
  • Semiautomatic system for ELISA 680 Bio-Rad (Bio-Rad)
  • IPS - thermoincubator microplate Microplate Reader 680
  • Automated Coagulation CA 1500 (Sysmex)
  • Immunohematology diagnostic system Scan Gel-based technology (Bio-Rad)
  • Semi-automatic workstation for parasitology research firm stool Diasysv

Analytical Equipment

  • Mass spectrometer MALDI-TOF microflex Bruker Daltonics (Germany) with the ability to accurately identify the causative agent in the shortest time
  • Automatic microbiological analyzer Walk Away 40 si (Dade Behring)
  • Antibiotikogramm Analyzer on Petri dishes Adajio (Bio Rad, USA) for expert evaluation of the data according to international standards CLSI and EUCAST.
  • Blood culture analyzer Bact Alert (Biomerioux, France)
  • Automatic MASTERCLAVE 09 with automatic module for filling media in Petri dishes APS320 (AES Laboratoire France)
  • Secure jobs in the pits of biological protection class 2 (ESCO, Singapore)
  • Autoclaves (Tutnauer)
  • Thermostats (Binder)
  • CO2 incubators (Sanyo)

IT Technologies

Laboratory information system includes a through bar-coding of all incoming samples, eliminates possible errors during manual labeling of the biomaterial, as well as to optimize the time of pre-analytical and postanalytical stages.Each sorted sample is assigned a unique barcode, which numbered in the laboratory information system is created and archived individual file containing all the information on the patient. Subsequently, each data file is supplemented analytical step, findings for each analyte and, if appropriate, comments medical laboratory.

Medical Laboratory Information System LIMS is fully adapted for integration with health information systems (Infoklinika, medialog, etc.), and allows you to carry out various forms of remote areas:

Remote Access - allows you to remotely monitor the results of research and making comments to our employees

Remote Login - registration and bar coding of samples forces medical facility – our partner, greatly simplifying the process of registration for admission tests in the laboratory and significantly speeds up the analysis phase of their treatment.

At the request of the medical center, research results can be sent via e-mail or by fax.

Quality Control

Multi-level system of quality control includes 4 levels:

I. Internal quality control (WCC) guarantees the accuracy of the results for each of the analyzed indicators and covers the pre-analytical, analytical and postanalytical stages

II. External quality assessment (EQA) is ensured by participation in three international (EQAS, RIQAS, Instand) and one domestic programs (FSVOK).

III. Quality Management System for NACPP built in accordance with the requirements of the standards:
- GOST R ISO 9001-2008 - "Quality Management Systems. Requirements "
- GOST R ISO 15189-2009 - "Medical Laboratories. Particular requirements for quality and competence "
- ISO / IEC 17025-2006 - "General requirements for the competence of testing and calibration laboratories"
- The scope of the certification includes absolutely all kinds of our activities that is unique to the situation on the market of medical services of the Russian Federation.

IV. Our laboratory is opened to external control / audits by the customer and inspections by authorities

Tags: