The tfives Compliance Journey powered by FIVES(TM) Framework

Integrated compliance solutions supporting the complete pharmaceutical product lifecycle—from discovery through lifecycle management.

One Platform. Five Stages. Complete Compliance. tfives is the only platform that provides integrated compliance from discovery through lifecycle. When you validate AI models in discovery, that documentation carries through clinical development, regulatory approval, commercial launch, and lifecycle management—eliminating redundant work and ensuring consistency.

Build Compliance into Innovation

Challenge: Preclinical data isn't GxP-compliant, AI models lack regulatory documentation

tfives Solutions:

  • ComplianceIQ: Validate AI models in target identification
  • ClinoxisCore: GxP data management from Day 1
  • DataGovernanceIQ: Secure patient-derived data

Key Outcomes:

  • AI models validated against 156 standards
  • Full GxP-compliant preclinical data
  • Audit-ready discovery documentation

Accelerate Clinical Development

Challenge: Protocol deviations, data integrity issues, safety signals missed

tfives Solutions:

  • ComplianceIQ: AI clinical trial design validation
  • Clinical Trial Compliance: Protocol monitoring
  • Pharmacovigilance: Automated AE detection
  • ClinoxisCore: GxP clinical data management

Key Outcomes:

  • Minimal major protocol deviations
  • Up to 1% faster database lock
  • Comprehensive timely AE reporting

First-Time Global Approval

Challenge: Multi-jurisdictional conflicts, AI documentation gaps, manufacturing readiness issues

tfives Solutions:

  • AskRexi: Multi-jurisdictional regulatory intelligence
  • ComplianceIQ: AI submission documentation
  • RegIQ: eCTD generation
  • ClinoxisCore: Regulatory data package validation
  • RegIQ: Pre-approval inspection readiness

Key Outcomes:

  • 99.7% first-time approval rate
  • Zero data integrity queries
  • Simultaneous global approvals

Commercialize at Scale

Challenge: HCP compliance tracking, promotional violations, manufacturing scale-up gaps

tfives Solutions:

  • CommercialCore: HCP & promotional compliance
  • MediusIQ: Launch evidence generation
  • RegIQ: Commercial-scale GMP
  • AskRexi: Post-approval change guidance

Key Outcomes:

  • Minimal commercial violations
  • Full Sunshine Act compliance
  • Launch evidence in weeks

Maximize Lifecycle Value

Challenge: Continuous safety monitoring, label expansions, ongoing GMP, generic competition

tfives Solutions:

  • Pharmacovigilance: Continuous safety monitoring
  • MediusIQ: Lifecycle evidence generation
  • RegIQ: Ongoing GMP
  • AskRexi: Post-market commitments
  • CommercialCore: Updated promotional compliance
  • ComplianceIQ: AI model lifecycle management

Key Outcomes:

  • Minimal post-market failures
  • Up to 40% faster label expansions
  • Minimal manufacturing recalls

One Platform, Five Stages, Complete Compliance

tfives is the only platform that provides integrated compliance from discovery through lifecycle. When you validate AI models in discovery (ComplianceIQ), that documentation carries through clinical development, regulatory approval, commercial launch, and lifecycle management—eliminating redundant work and ensuring consistency.

Discovery AI Model
(ComplianceIQ validated)
Development Clinical Trial
(Same AI model documentation)
Approval Regulatory Submission
(AI validation package ready)
Launch Commercial Deployment
(AI compliance maintained)
Lifecycle+ Model Updates
(Continuous validation)