«Medsi»

Group of companies «Medsi», the largest private Federal network of medical clinics in the Russian Federation, began conducting of clinical trials at its base. The first two agreements were signed with OOO "Ligand Research", contract research organization, to conduct cardiological and endocrinological clinical trials, the sponsor of which is the Japanese company OOO "Takeda Pharmaceutical". To "Medsi" clinical trials is a new activity. Until the end of the year it is planned to broaden the base for clinical trials in other hospitals within the network. There have been no clinical trials at the clinical base for 20 years of the clinics existence. 

GCP training for professionals of pharmaceutical industry (basic course).

8 - 9 June 2012, Moscow.

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Fotos from the training on a facebook page.

Principles of observational studies

Seminar for the specialists in marketing and clinical studies. 9 April 2012, Moscow.

  • Importance of epidemiology for pharmaceutical market.
  • Observational studies in medical science and in pharmaceutical business.
  • Types of observatio    Standard GEP (Good Epidemiological Practice).
  • Observational studies and legal rules.
  • Data management and statistical analyses in observational studies.
  • Ethical aspects of observational studies.
  • Publication of the results. Standard STROBE (STrengthening in the Reporting of OBservational studies in Epidemiology).

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Photos

"GCP for investigators. Introductory level" Haematology Scientific Centre of RAMS 2-3 March 2012.

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Photos on a facebook page

'GCP for investigators. Introductory course'. Federal Centre of Children Haemotology, Oncology and Immunology. Moscow, 24-25 February, 2012.

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Fotos

Seminar 'Studies of Drugs Equivalence'. Moscow, 29 August 2011.

Program

  • New generic drugs: history, conglicts and trends.
  • Principles of drug equivalence assessment.
  • Biosimilars. Features of investigation and registration.
  • GLP (Good Laboratory Practice) in bioanalytics.
  • Bioanalytical laboratory – view from the trench.
  • Legal rules and BABE studies.
  • Clinical part of BABE study.
  • Therapeutical equivalence studies.
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GCP for study nurses. 11-12 August 2011.

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Fotos

GCP training in Vishnevsky's Institute of Surgery.

Moscow, 16-17 August, 2011.

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Fors

  • Data management&Statistics

    Data management

    • Paper and web-based CRF
    • Data base (SQL)
    • Double entry
    • System of QA/QC data entry process
    • Coding
    Learn more >>
  • Study concept&protocol

    • Study concept development
    • Collaboration with medical experts
    • Protocol writing
    • Protocol reviewing/adaptation
    • Protocol translation/verification
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  • Monitoring&Audit

    • Monitoring is performed by high qualified and experienced CRAs internal system of CRA training most CRAs have MD qualification
    • Regular internal audit of office,clinical sites and laboratory clinical facilities
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  • Consulting

    • Assistance in the process of registration
    • Document preparation/submission
    • Monitoring of the registration process
    • Drug supply / customs procedures / local partner depoy
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  • Trainings

    • Statistical model development
    • SPSS, SAS
    • Statistical analyses/statistical report
    • Possibility of DSMB organization
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  • Phase I/PK Units

    • I-st phase
      • First-into-Man
      • Microdosing studies
      • Interaction studies
    • Special populations PK studies
    Learn more >>
  • IVRS

     
    Learn more >>
  • Final Report

    • Statistical report
      • Final study report
      • ICH E3 standard
    Learn more >>
  • Phase II-IV

    • Development&Writing
      • protocol
      • case report form (CRF)
      • database
      • investigator's brochure
    Learn more >>
  • PK Units

    • 2 Hospital based units for PK-sessions
    • Wards with possibility of simultaneous dosing in 18 patients
    • Trained medical staff
    • Core medical team experience in PK studies since 2008
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  • Study Management

    • Project management
    • Logistic solutions
    • Payment optimisation
    • PK units/PK session organisation
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  • Observational studies

    Seminar for the specialists in marketing and clinical studies. 9 April 2012, Moscow.

    • Importance of epidemiology for pharmaceutical market.
    • Observational studies in medical science and in pharmaceutical business.
    Learn more >>