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

  • Clinical Data Management Systems (CDMS)
    • Oracle Clinical: Expert support 
    • Oracle Data Management Workbench (DMW): Study Build and Study , admin tasks, TMS configuration incl. primary indication to support high-level ATC coding of ConMed terms in TMS, Configure Blinding of input model and tables in DMW, Validate Batch and Validate Checks
    • Oracle Life Sciences Data Hub (LSH): Custom programming of Validation Checks, Custom programs (functions) for Oracle DMW, Custom procedure to populate filter table, Study Data Extract from LSH database
    • Oracle Thesaurus Management (TMS): Setup MedDRA and WHODrug B3 dictionary, Dictionary Load scripts / Dictionary upgrade, High-level ATC coding / Indication Coding of ConMed terms.
    • Oracle InForm (EDC) and other EDC systems
  • CDISC Standards: SDTM – Study Data Tabulation Model – and SEND – Standard Exchange of Non-clinical Data
  • Test and Validation of GxP Systems (Risk based approach)
  • System Strategy and Enterprise Architecture
  • Interfaces / Automated File Transfers / Data Extracts

We have more than:

  • 20+ years experience from the pharmaceutical industry / Data Management
  • 20+ 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), TMS 5.3 for Oracle DMW, Oracle DMW, Oracle LSH, Oracle Analytics Cloud (OAC).
  • 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