IT Consulting Services for the the Pharmaceutical Industry and Life Sciences

Full service IT Consultancy providing business/process know how and expertise for IT systems used in the pharmaceutical industry (Clinical Operations) for conducting clinical trials but also IT systems used in Non-Clinical Development (Global Research, R&D) for conducting pre-clinical trials.

Typical consulting services include system analysis, installations, upgrades, application support (technical and functional), custom development, programming, extracts and reporting. Depending on the projects I work alone or together with partners in my network.

Custom Development Projects for Oracle DMW / LSH / TMS

  • TMS: Setup MedDRA and WHODrug B3 Global dictionary in TMS for DMW
  • TMS: Upgrade MedDRA and WHODrug dictionaries in TMS
  • DMW Administration: Setup TMS question sets for MedDRA and WHODrug
  • DMW: Configure Study and tables in DMW for TMS coding including primary indication for TMS
  • DMW: Validation Batch and Validation Checks
  • LSH:
    • Custom function to lookup and return country ISO 2-letter or 3-letter alpha code from site country name
    • Custom package (function) to check and remove illegal characters (non-printable ASCII chars) from AE, MH and CM terms in DMW.
    • Custom function to lookup and return full list of ATC codes for ConMed term with multiple ATCs
    • Custom function to generate random value for blinding purpose of lab results
    • Custom fuction to return date and time in CDISC format
    • Programming of Validation Checks for study in DMW
    • Study Data Extract from LSH database

Custom Development Projects for Oracle Clinical / TMS

  • Customized Oracle Forms/Oracle Reports for Oracle Clinical (fully integrated via User Menu)
  • Extract Serious Adverse Events patient cases from OC in XML format for import to Aris Global
  • Generic Reporting module for Oracle Clinical with extract to PDF/Excel
  • Adverse Events Listings for Oracle Clinical with extract to PDF/Excel
  • Automated Surveillance tools for Oracle Clinical database
  • Customized roles to menus in OC for e.g. external CRO/LAB users
  • Interfaces to Oracle Clinical from other IT systems

Custom Development Projects for TMS (Thesuarus Management System)

  • Dictionary Setup in TMS
  • Load scripts for MedDRA and WHODrug
  • Dictionary upgrade of MedDRA and WHODrug (B2 and B3) in TMS
  • Development and implementation of drill-down views
  • SQL listing of coded terms (VTAs) pending approval with output to Excel
  • SOP for Dictionary Management
  • Synonym Review Report

Custom Interface for Oracle Clinical and Impact (CTMS system by Parexel) 

  • Development of 2-ways interface for OC and IMPACT
    • OC: Send patient visits to IMPACT for trial status and progress
    • IMPACT: Send Sites, Investigators and Patients to OC