CRO MOSCOW
Prime clinical quality
CLINICAL TRIALS
CRO MOSCOW provides a range of services for conducting phase I-IV clinical trials of medicines to pharmaceutical and biotechnology companies in the Russian Federation and CIS countries:
Monitoring and co-monitoring of research centers (I-IV phases)
Development of study design and protocols
Development of individual registration cards
Development of patient information and informed consent forms
Assessment of the possibility of conducting a study (Study feasibility)
Selection of research centers
Storage and handling of study materials
Interaction with regulatory authorities
Interaction with central and local ethics committees
Bioequivalence and bioavailability studies
Project management
Control of the financial aspects of the study
Organization and holding of kick-off and intermediate meetings of researchers
Translation of clinical trial documentation
Monitoring and co-monitoring of research centers (I-IV phases)
Development of study design and protocols
Development of individual registration cards
Development of patient information and informed consent forms
Assessment of the possibility of conducting a study (Study feasibility)
Selection of research centers
Storage and handling of study materials
Interaction with regulatory authorities
Interaction with central and local ethics committees
Bioequivalence and bioavailability studies
Project management
Control of the financial aspects of the study
Organization and holding of kick-off and intermediate meetings of researchers
Translation of clinical trial documentation
DATA MANAGEMENT
CRO MOSCOW provides services for the processing of data obtained in the course of clinical trials, with the guarantee of confidentiality and data safety.
Development and creation of bases
Data management
Data entry and verification
Validation
Data quality control and generation of requests for problematic data to research centers
We also provide services for statistical analysis of the results of clinical trials with a guarantee of confidentiality and safety of the data provided. Statistical analysis services include consultations, development and implementation of statistical analysis of a clinical trial, as well as the preparation of a final report.
Development and creation of bases
Data management
Data entry and verification
Validation
Data quality control and generation of requests for problematic data to research centers
We also provide services for statistical analysis of the results of clinical trials with a guarantee of confidentiality and safety of the data provided. Statistical analysis services include consultations, development and implementation of statistical analysis of a clinical trial, as well as the preparation of a final report.
REGISTRATION SERVICES
We provide a full range of services for the registration in the Russian Federation of Russian and foreign medicines, pharmaceutical substances, dietary supplements, medical equipment and medical products.
The scope of our activities covers all aspects of the above processes:
Preparation of documentation for product registration in accordance with the current legislation of the Russian Federation.
Coordination of the registration process at all stages.
Registration of changes made by companies during the period of validity of the product registration certificate.
Carrying out re-registration of the product after the expiration of the registration certificate.
The scope of our activities covers all aspects of the above processes:
Preparation of documentation for product registration in accordance with the current legislation of the Russian Federation.
Coordination of the registration process at all stages.
Registration of changes made by companies during the period of validity of the product registration certificate.
Carrying out re-registration of the product after the expiration of the registration certificate.
QUALITY CONTROL
We have a quality control department operating in accordance with our own standard operating procedures (SOPs) that comply with all international standards, which allows us to:
Guarantee the high quality of the services provided.
Provide oversight of clinical trials.
Provide pharmaceutical companies with independent audit services for research centers in Russia and CIS countries.
Guarantee the high quality of the services provided.
Provide oversight of clinical trials.
Provide pharmaceutical companies with independent audit services for research centers in Russia and CIS countries.
CONSULTING SERVICES
We provide advisory services for domestic and foreign pharmaceutical and biotechnology companies, contract research organizations, consulting companies, government commissions and interested public organizations.
Consulting services include the following main provisions:
Assessment of the possibility of conducting a clinical trial in the Russian Federation, in the CIS countries.
Assessing the capabilities of research centers.
Selection of centers taking into account the requirements of the protocol and the wishes of the Client.
Assessment of the prospects of national markets for the commercial sale of a registered product.
Consulting services include the following main provisions:
Assessment of the possibility of conducting a clinical trial in the Russian Federation, in the CIS countries.
Assessing the capabilities of research centers.
Selection of centers taking into account the requirements of the protocol and the wishes of the Client.
Assessment of the prospects of national markets for the commercial sale of a registered product.
About us
Contract research organization CRO MOSCOW provides a full range of services for the Russian and international pharmaceutical business.