OUR ACTIVITIES
CLINICAL AND PRE-CLINICAL RESEARCH
Research data management
LLC "MRC" provides a range of services for the collection, transfer of information obtained in the course of clinical studies into an electronic database for further analysis.

At the stage of research organization:
  • Development and design of KFM
  • Development of a data management plan
  • Database design and testing
  • Development of a statistical analysis plan
  • Creation of randomization codes

At the research stage:
  • Database management, data entry
  • Data coding (AE / SAE, diagnoses, drugs, etc.)
  • Data discrepancy management;Review data (current QC)

At the research completion stage:
  • Harmonization of data on SAE
  • Data control
  • Closing the database
  • Archiving of electronic data
  • Data analysis
  • Preparation of a statistical report
    Monitoring
    –°linical research specialists of LLC "MRC" provide a full range of services for testing the safety of subjects, compliance with the protocol, GCP, national legislation and the quality of data collection.

    • Conducting qualification visits, initiation visits, routine monitoring visits, center closure visits
    • Interaction with research centers
    • Conducting trainings for researchers
    • Verification of informed consent of patients
    • Verification of patients' compliance with the protocol criteria
    • Checking the file of the researcher to ensure the proper management and storage of documents
    • Checking data in research centers, including primary documentation and completed CRF
    • Collection of research documents, including regulatory documentation
    • Accounting for the investigational drug and the reference drug;
    • Tracking the status of the recruitment of patients in each center
    • Verification of SAE reports
    • QUERY management
    Project management
    LLC "MRC" coordinates and manages projects from start to finish:

    • Continuous interaction with the customer on the status and issues of the current research in the format of scheduled meetings, reports, unscheduled communication, telephone conversations, e-mail
    • Monitoring the actions of the project team
    • Trainings for project team members
    • Identification of potential problems and search for solutions
    • Tracking study status, including patient recruitment status
    • Interact with research teams and ensure that clinical trials are strictly adhered to with the ICH GCP / FDA / EMA and ICH GCP / FDA / EMA protocol, timeline, budget and legislation
    • Motivating research doctors to accelerate patient recruitment
    • Verification and participation in the creation of project-specific documentation (manuals, instructions)
    • Checking monitoring reports
    • Conducting joint monitoring visits
    Development of clinical trial documents
    LLC "MRC" develops a package of documents for all types of clinical trials: protocol, informed consent, investigator's brochure, paper or electronic CRF, patient diary (if necessary).
    Our goal is to provide an optimal solution for performing clinical trials with the aim of subsequent registration of the studied medicinal product.
    Biostatistics
    LLC "MRC" offers the main range of decision-making services in terms of statistical analysis for all stages of clinical trials and non-interventional observational research:

    • Design selection for phase I-III clinical trials and sampling method for observational studies
    • Statistical support and consulting when writing a research protocol
    • Services for the creation of randomization lists with different approaches to randomization
    • Creation of a statistical analysis plan
    • Interim statistical analysis (blinded and blinded);
    • Writing a statistical report and statistical sections in an integrated clinical report
    • Help in creating presentations on the results of clinical trials and observational studies
    Post-marketing research
    Post-marketing (observational, non-interventional) programs are studies aimed at collecting data on the safety and tolerability of a registered medicinal product.
    LLC "MRC" provides a full range of services for post-marketing (observational, non-interventional) research:

    • A package of documents is being developed (protocol of the post-marketing observational program, informed consent for patients, paper or electronic CRF)
    • Clinical bases for conducting these studies are selected
    • Monitoring, data management and statistical processing of research results are carried out
    • The final research report is being prepared
    Pharmacovigilance
    Pharmacovigilance or drug safety monitoring is an activity aimed at identifying, assessing, understanding and preventing the unwanted effects of drug use.

    LLC "MRC" offers a wide range of services at all stages of building a pharmacovigilance system:

    • Security data management, receipt, processing and handling of Individual Security Cases
    • Maintaining a security database
    • Screening of specialized literature and information resources (local and global)
    • Development and maintenance of the pharmacovigilance system master file
    • Writing POBLS (periodic updated reports on drug safety);
    • Allocation of an authorized person for pharmacovigilance and local contact persons for pharmacovigilance
    • Development of the necessary SOPs with templates, logs and forms for them necessary for the functioning of the pharmacovigilance system and the quality department
    • Training
    • Periodic internal audits of the company
    • Consulting on pharmacovigilance and quality issues
    • Writing Risk Management Plans
    • Processing of claims for the quality of drugs
    • Transfer of information about CPD to regulatory authorities
    • Medical examination of safety cases
    Registration of medicines / medical devices
    LLC "MRC" offers a comprehensive package of services for the state registration of medicinal products and its confirmation in the EAEU, as well as amendments to the registration dossier for registered medicinal products in Russia.
    Audit
    LLC "MRC" operates according to its own system of Standard Operating Procedures (SOP). At the request of the customer and with appropriate trainings, he can work according to the customer's SOPs:

    • Organization and conduct of independent audits of CI / research centers
    • Conducting independent audits of partners of clinical / preclinical research (laboratories, research centers, bases for conducting preclinical research)
    • Internal independent audit of the company's pharmacovigilance system;
    Marketing research
    LLC "MRC" creates analytical reviews and conducts marketing research on segments of the pharmaceutical market. In the reviews, it is presented for the segment under study: historical background, current status in the world and Russian markets, economic statistics, options for implementing a project in a segment, forecast for a segment. A unique product is created exclusively according to customer requirements and allows you to determine the further development strategy.
    Distribution of medicines
    LLC "MRC" is a distributor of medicines.