Our organization offers its services on arrangement and performance of clinical studies of pharmaceuticals on the territory of Eastern Europe .
Preparation of reports on clinical studies in phases I-IV.
Obtaining a permission to perform clinical studies from Ministry of Health.
Monitoring and co-monitoring of international and local clinical studies in phases II-IV.
Arrangement and holding of initial, intermediate and final research meetings.
Designing of clinical studies in phases I-IV.
Our services on processing data obtained during clinical studies (Data Management) and carrying out their statistical analysis include
Development and generation of databases
Data acquisition and management
Data input and verification
Data quality assurance and generation of requests to research centers
Consultations, development and carrying out the statistical analysis of clinical studies
Preparation of statistical, medical and integrated reports on respective studies
Data safety and confidentiality
NBScience offers its services on performance of laboratory tests in the context of clinical studies in phases II-IV in one Central laboratory
Cutting-edge laboratory equipment
National certificates for all types of analyses.
Performance of the following laboratory studies:
overall blood analysis , biochemical analysis , lipid profile, coagulation status,diabetic indices, immune markers , hormonal status, Storage of samples for laboratory studies during 7-10 days to perform their re-tests.
A range of services rendered by our company includes the approval of laboratory tests for a report and development of laboratory research instructions.
Our organization is engaged in multiple fields, which enables for a comprehensive approach in accomplishing various tasks.
The services offered by us are as follows:
Supplies of essential preparations, medical equipment and accompanying materials to research centers.
Storage and distribution of pharmaceuticals among research centers in accordance with ICH GCP rules and a sponsor’s terms and conditions.
Collection of pharmaceuticals from clinical centers after the completion of their studies: removal or destruction of pharmaceuticals.
In the context of performing the studies, our company forms the contracts with clinical centers and researchers, controls payments under contracts as well as provides a legal and information support of clinical studies.
In Vivo Bioequivalence
The Laboratory of Bioequivalence and Molecular Biology provides full assistance in:
In vivo bioequivalence trial design
Preparation and review of Case Report Forms (CRFs)
Preparation of Informed Consent Form (ICF)
Preparation and translation of the Protocol/ammendments (in compliance with ANMAT, FDA, ICH, GCP)
Selection of the clinical study site and investigators
Regulatory approvals (Local Ethics Committee, IRB/IEC, National Regulatory agency ANMAT)
Drug Plasma concentration determination method
Research and development
Statistical analysis and report
Final clinical and statistical report
The Laboratory's facilities include two ThermoSeparation HPLCs, with autosampler and variable wavelength UV detector.
We also offer the possibility to analyze samples with other detection methodologies, such as GC, LC-MS/MS, RIA, EIA, etc.
HPLC and all other support equipment (centrifuges, scales, evaporator, etc) are periodically calibrated according to global and consistent Standard Operating Procedures (SOPs).
Similar or generics?
An original or innovator drug: is the one that contains a new active ingredient on which a complete research and development has been made. It is therefore the first, and sometimes the only one, that contributes to own data of security and therapeutic effectiveness. The developing, proprietary laboratory of the rights, commercializes it under a registered brand-name. Once the patent rights expired, the active ingredients contained in innovator products can be commercialized freely by different laboratories.
A generic drug: is a medicine with the same pharmaceutical form and equal qualitative and quantitative composition than the innovator product. It must demonstrate therapeutic equivalence by means of bioequivalence studies. The generic drug is interchangeable with the reference product since they have the same therapeutic effectiveness. They can only be commercialized once the patent of the innovator brand-name product has expired.
Design of a Bioequivalence Study
In the design of an In vivo Bioequivalence study, it is important to consider the following issues:
Study Purpose: drug development, local regulatory requirements, global market goals, marketing.
Drug characteristics: analytical method to be used for its quantization, half life of the drug that will determine the study timelines, eventual adverse events, etc. All these matters affect both study costs and ethical and regulatory issues.
Clinical Study Site and Analytical Laboratory selection: compliance with GCP, GLP, SOPs and certifications.
Study population: number of volunteers to be enrolled in the study, depending on the aims of the study and drug variability, which can be estimated from bibliography or a pilot study.
Study design: simple cross-over (AB/BA) or replicate (ABAB/BABA). The replicate design reduces the sample size (N) but lengthens study times. Group sequential design may also be proposed.
Standard Operating Procedures (SOPs)
In compliance with Good Laboratory Practices (GLP), the Laboratory of Bioequivalence and Molecular Biology has created the following Standard Operating Procedures (SOPs) which are constantly revised and updated.
Standard Operating Procedures for the Validations of analytical methods
Standard Operating Procedures for use and maintenance of Laboratory Notebooks
Authorized personnel for calibration and maintenance of Laboratory equipment.
Standard Operating Procedures for methods of clean-up and decontamination in the Laboratory
Standard Operating Procedures for handling and waste of fluids with biological hazard risk: serum, plasma and human blood.
Standard Operating Procedures for handling of hazardous drugs and materials.
Standard Operating Procedures for Hazardous waste
Standard Operating Procedures transport and reception of biological hazardous materials
Standard Operating Procedures calibration and maintenance of HPLC
Standard Operating Procedures for the control of refrigerated transport of plasma samples
Standard Operating Procedures for maintenance and calibration of Weigh Balances
Standard Operating Procedures for maintenance and calibration of thermostatic bath
Standard Operating Procedures for maintenance and calibration of the pHmeter
Standard Operating Procedures for maintenance and calibration of the N2-evaporator
Standard Operating Procedures for the use and calibration of micropipettes
Standard Operating Procedures for guidelines of sample re-analysis criteria
Standard Operating Procedures for records and archives
Standard Operating Procedures for preparation and review of standard operating procedures
At the Laboratory of Bioequivalence and Molecular Biology we validate the analytical methods according to ICH guidances, evaluating the following parameters:
Selectivity / specificity
Precision (Precision, Intra-analysis precision, intermediate precision)
Linearity and range
Limit of Detection
Limit of Quantification
Accuracy / Recovery
Recovery of the plasma extraction method
Stability of the drug in plasma at -20oC, room temperature and freeze/thaw cycles
At present, we have validated analytical methods for the following antiretrovirals and we are currently undergoing validations for the simultaneous determination of antiretrovirals and other drugs according the need of our clients.
Date will be selected on the basis of feedback from participants.
The success of the NBScience international is built on forging profitable business relationships between the Pharmaceutical and Biotechnology industries and their partners in clinical research.
With our 5 years of experience in increasing our partners' return on investment we've developed winning strategies guaranteed to build and sustain successful partnerships in clinical trials outsourcing.
NBScience already has many partnerships with societies, universities, statutory organisations and NGOs locally, nationally and internationally. We aim to strengthen these relationships and develop new collaborations in the future.