Data management

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

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

• 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

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

• Statistical model development
• SPSS, SAS
• Statistical analyses/statistical report
• Possibility of DSMB organization

• I-st phase
  • First-into-Man
  • Microdosing studies
  • Interaction studies
• Special populations PK studies

• Statistical report
  • Final study report
  • ICH E3 standard

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

• 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

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

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.