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.
- IT System Management (ITMS)
- IT System Strategy
- IT System Landscape
- IT Infrastructure
- IT Security
- Secure file transfer, Encryption methods, Password security
- Interfaces between IT Systems
- File Transfer
- IT System Upgrades
- IT System Releases
- IT System Corrections
- Patch Evaluations
- Critical Patch Updates
- Hardware (HW) upgrades / replacement
- Software (SW) update / installations
- Support timelines
Custom Development Projects for Oracle Clinical
- 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