| Key features | - Connect and sync source documents across SharePoint, Box, Google Drive, and other systems
- Real-time submission readiness tracking combining validation findings, drafting progress, and risk signals
- Automated deadline-driven workflows with validation, drafting, routing, and readiness checks at T-30, T-14, and T-3
- 21 CFR Part 11 and EU Annex 11 compliant audit trails with role-based access
- eCTD structure, lifecycle, and metadata validation before submission
- eSTAR completeness, evidence packaging, and filing readiness validation for medical devices
- Multi-jurisdiction coordination with FDA, EMA, and Health Canada workflow support
- Sponsor isolation controls for CROs with separate document storage, access controls, and audit trails per sponsor
- Sponsor read-only dashboard for real-time program status and readiness scoring
- Repeatable workflows and pre-configured templates for rapid sponsor onboarding
| - 70+ million monthly verifications
- 500+ risk signals across identity, integrity, intent, income and influence
- Real-time fraud detection and prevention
- Video KYC and zero-touch onboarding
- No-code drag-and-drop workflow customization
- ISO 27001 and SOC 2 Type 2 certified
- Sub-200ms API response times
- Transaction Intelligence Platform for income and spending analysis
- CrimeCheck for criminal and litigation risk screening
- Plug and play API integration
|
|---|
| What makes it different | - Recovers 100+ hours and avoids $150-250K in rework and filing delay costs per submission
- Reduces eCTD and eSTAR defects before filing through continuous validation during drafting
- Eliminates version drift and manual status reporting with shared comments and real-time traceability
- Standardizes CRO workflows across multiple sponsors without per-sponsor customization
- Enables lean teams to handle 3x more submission capacity without expanding headcount
| - Sub-200ms real-time API responses for immediate fraud detection at point of entry
- Multi-layered defense combining identity, transaction, behavioral and database checks
- Explainable risk decisions with reasons for every score for audit and dispute handling
- Proprietary data access including court records and exclusive fraud networks unavailable elsewhere
|
|---|
Assyro AI
IDfy