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
- Clinical 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