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We offer IT Consulting Services to the Pharmaceutical Industry and Life Sciences in the following areas:

  • CDISC Standards
    • SDTM – Study Data Tabulation Model
    • SEND – Standard Exchange of Non-clinical Data
  • System Development
  • Software / Hardware installation and checklists
  • Computer System Validation (CSV)
  • Validation Documentation
  • System Strategy
  • System Landscapes
  • Enterprise Architecture
  • Interfaces
  • Automated File Transfer using Repliweb MFT (Managed File Transfer)
  • Testing/Validation Services
  • Infrastructure
  • Backup/Disaster/Recovery
  • Risk Assessment

We have more than:

  • 20+ years experience from the pharmaceutical industry
  • 18+¬†years experience from with Oracle Clinical/TMS versions 3.2, 4.0.3, 4.5.1, 4.6.6, 5.1, 5.2 and 5.2.1 (TMS patch with support for WHO Drug B3 format)
  • 20 years experience with Oracle Systems Development
    • Oracle RDBMS 7.x, 8i, 9i, 10g, 11gR2, 12c
    • Oracle Developer Suite 10g, 11g and 12c
      • Oracle Forms Builder
      • Oracle Reports Builder
      • SQL PLus, SQL Developer, TOAD (Tool for Oracle Application Developers)
      • PL/SQL Programming