The Challenge
As one of the world's leading CROs, this organization manages regulatory submissions for dozens of pharmaceutical and biotech sponsors simultaneously. Each sponsor requires complete data isolation, different workflows, and often different regional requirements.
Key Challenges
- Managing 40+ sponsor accounts with complete data separation
- Different validation rules and workflows for each sponsor
- Audit requirements demanding proof of data isolation
- Scaling team without proportional headcount increases
- Supporting 5+ regulatory regions with different requirements
Our previous system couldn't scale. We were managing sponsor data in silos, duplicating effort, and constantly worried about cross-contamination. One wrong click could expose confidential sponsor data.
The Solution
DNXT Publisher's multi-tenant architecture was purpose-built for exactly this scenario. Each sponsor operates in a completely isolated environment while the CRO maintains centralized visibility and management.
Multi-Tenant Implementation
- Database-Level Isolation: Each sponsor's data in separate, encrypted database instances
- Configurable Workflows: Sponsor-specific validation rules and approval processes
- Role-Based Access: Granular permissions ensuring staff only see assigned sponsors
- Centralized Reporting: CRO leadership dashboards across all sponsors
- White-Label Options: Sponsor-branded portals where needed
Security & Compliance Features
The Results
Within 12 months, the CRO had migrated all 40+ sponsors to DNXT Publisher and onboarded 8 new sponsors without adding regulatory operations headcount.
Measurable Outcomes
- 60% efficiency improvement: More submissions with same team size
- 100% audit compliance: Passed all sponsor and regulatory audits
- Zero data incidents: No cross-sponsor data exposure in 3+ years
- 8 new sponsors onboarded: Without additional headcount
- Standardized best practices: Across all sponsor accounts
DNXT's multi-tenant architecture is a game-changer for CROs. We can onboard a new sponsor in days, not months. Each sponsor gets enterprise-grade capabilities without us managing 40 separate systems.
Sponsor Benefits
The CRO's sponsors also benefited significantly from the implementation:
- Faster project starts: New studies begin with validated infrastructure from day one
- Reduced oversight burden: Confidence in data security reduces audit requirements
- Better visibility: Sponsor dashboards provide real-time submission status
- Consistent quality: Standardized processes across all CRO projects
Looking Ahead
The CRO is now expanding their DNXT implementation to include AI-powered document analysis and predictive analytics for submission planning. They're also piloting a sponsor self-service portal for direct document uploads.
