Cnr Ja
All for new pharmaceutical development, drug registration and medical marketing
• A full service international pharmaceutical business.
• We are a team of ambitious professionals who understand the essence of research.
• Our priorities are careful treatment of study participants, clarity and transparency in our work, quality and reliable data.
  • CLINICAL TRIALS
    CRO SABISU provides services for conducting Phase I—IV clinical trials of medicines to pharmaceutical and biotech companies worldwide
    • Development of study design and protocols
    • Development of Case Report Form (CRF)
    • Development of patient information and informed consent forms
    • Study feasibility, study centers selection
    • Storage and handling of study materials
    • Interaction with regulators, organization of independent data monitoring committees.
    • Interaction with central and local ethics committees
    • Project management and financial control
    • Monitoring and co-monitoring of Study centers (Phases I—IV)
    • Organization and conduct of start-up and interim meetings of researchers
    • Translation of clinical trial documentation
  • PSYCHO-
    LOGICAL AND RELATED SUPPORT FOR CLINICAL TRIAL PARTICIPANTS
    • Possibility of remote psychological guidance, in the language of the study participant
    • Automated systems for collecting information about the condition of a research participant (validated questionnaires, assessment scales, integrated databases)
    • Offering the opportunity to participate in a formal clinical trial, depending on their availability in the relevant territory
    • Support during all phases of the clinical trial, as well as at the end of the trial
    • Supporting members of patient communities from wherever a person is located
  • DATA MANAGEMENT
    • Database development and building
    • Data management
    • Data entry and verification
    • Data quality control and generation of queries on problematic data to research centers
    • We also provide services for conducting statistical analysis of clinical trial results with a guarantee of confidentiality and safety of the data provided. Statistical analysis services include consultations, the development and conduct of a 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 registration of medicines, pharmaceutical substances, medical equipment and medical devices.
    Our field of activity covers all aspects of such processes as
    • preparation of documentation for product registration in accordance with the current legislation of the country of registration
    • coordination of the registration process at all stages
    • registration of changes during the validity period of the product registration certificate
    • re-registration of the product after the expiration of the registration certificate
  • ADVICE ON CLINICAL AND PRE-CLINICAL STUDIES (FROM IN SILICO STAGE TO PRODUCT REGISTRATION)
    We provide advisory services to pharmaceutical and biotechnology companies, as well as interested public organizations such as physician and patient communities.
    We provide guidelines and support in the following main points:
    • assessment of the possibility of conducting a clinical trial in the relevant country
    • selection of centers based on protocol requirements and Client's Requests
    • assessment of the prospects of national markets for the commercial sale of a registered product
    • advising, organizing, supporting, quality control, and reporting on preclinical and clinical trials at all stages
Contacts
Phone: +381 614 854 067
Email: team@sabisudo.me
Alyona Molchanova
Natalia Ardaeva
Ilino BB, Bar, 85000, Montenegro