As a trusted technology partner of Oracle, Techsol is specialized in providing fully-managed cloud and professional consulting services for drug safety, signal management, PV operations management, compliance governance and advanced data analytics.

Oracle Argus
PV Professional | Argus Safety, Empirica & Gateway Setup Services
  • Fast track implementation & validation with accelerators
  • Setup and test on Oracle Cloud or Customer Cloud
  • E2B Gateway Setup & Exchange Test (FDA, PMDA, Health Canada, B2B, etc.)
  • Case Data Migration & Verification
  • Argus Version Upgrade & Testing
  • Integration Setup with EDC & Signal Management systems
  • GxP Validation Documentation (IQ/OQ/PQ)
  • Computer System Assurance for 21 CFR Part 11 Compliance
PV Professional | Specialized Argus Safety Configuration Support

Our Argus certified SMEs offer extensive technical and functional guidance to configure:

  • Products, Studies and associated workflows
  • Auto-narratives and letter generation
  • Global Reporting Rules
  • Dictionary Management (MedDRA English & Japan, WHO Drug)
  • Users & Roles Administration
  • Query & Reporting Services
  • Signal Management
PV Professional | Reporting & Analytics

Based on your regulatory needs, we can setup and automate the schedule for generating the following regulatory reports:

  • ICH: E2B R3 electronic data submission
  • ICH: E2C periodic safety update report (PSUR)
  • ICH clinical trial periodic report and EUSAR
  • IND and NDA periodic report
  • CIOMS II line listing and CIOMS V
  • EMEA/CPMP reporting
  • Offer support for custom reporting using advanced analytics platforms
Techsolcorp | PV Professional Services - Business Process Consulting

Based on your requirements, we can offer functional domain expertise for:

  • Business Process Design for end-to-end Case Management
  • Reconciliation with clinical systems
  • Setup of Signal Management
  • Configuration of process specific compliance reports and productivity dashboards
  • Support for reports generation in E2B (R3) & E2B (R2) formats
  • Argus DLP integrated safety case summaries
PV Professional | Argus Service Desk
  • 24×7 SLA Driven Technical & Functional Support (Requests, Incidents & Change)
  • Argus User Management & Roles Administration
  • Ongoing Configuration Management
  • Periodic Patch Deployments
  • Medical Dictionary Management
  • Safety Cloud Preventive Maintenance
PV Professional | Other Specialized Services
  • Business Process Consulting for mergers & acquisitions
  • End User & Administration Training
  • Regulatory Inspections & Audit Support
  • Disaster Recovery & Business Continuity