Simplify Pharmacovigilance from Start to Go-Live
Implement fully compliant safety systems with expert-led planning, configuration, and validation.
Our Implementation Services
We provide a full range of services to help you plan, configure, validate, and support your PV system—all tailored to your organization's specific needs.
System Selection & Planning
We assess your needs and recommend the right system—like Argus, ARISg, or Veeva—and build a clear project plan with milestones to guide your implementation.
System Configuration
Custom workflows, user roles, data fields, and case routing logic—all set up according to your SOPs and compliance strategy.
Compliance Alignment
We ensure your system meets international standards like ICH E2B, FDA 21 CFR Part 11, EMA GVP modules, GxP, and GDPR.
Data Migration & Integration
Migrate your legacy safety data and connect your PV system with other tools like CTMS, EDC, and medical info platforms.
E2B Configuration & Gateway Setup
We enable automated ICSR submissions by configuring your system for secure gateway communication with health authorities.
Testing & Validation
We perform complete system validation (IQ/OQ/PQ) to ensure your PV platform works correctly and meets regulatory expectations.