Phase II- IV

phase2

  • Development&Writing

-         protocol

-         case report form (CRF)

-         database

-         investigator's brochure

  • Regulatory activities: file preparation/submission
  • Organization of drug supply / custom procedures / local depot
  • Site selection / feasibility assessment

-         database of potential sites/investigators in different medical areas

-         two PK-studies sites

  • Organisation of trainings/meetings
  • On-site monitoring
  • Site-management
  • Statistical&Final reports
  • Archiving

  • Data management&Statistics

    Data management

    • Paper and web-based CRF
    • Data base (SQL)
    • Double entry
    • System of QA/QC data entry process
    • Coding
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  • 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
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  • IVRS

     
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  • Final Report

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

    • Development&Writing
      • protocol
      • case report form (CRF)
      • database
      • investigator's brochure
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  • 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.
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