Solutions by Use Case

Find the Right Solution for Your Specific Compliance Challenge

Compliance in a Box. Built for Every

Life Sciences Organization.

From AI governance to commercial operations, from manufacturing to clinical trials—TFives provides

targeted solutions for every pharmaceutical compliance use case.

Strategic implementation and validation services powered by

proprietary accelerators. We don't just advise—we deliver. 10x faster than

traditional consulting with outcomes-based delivery.

Five Major Use Case Categories

Five Major
Use Case Categories

TFives solutions are organized into five comprehensive bundles, each addressing specific pharmaceutical compliance challenges.

TFives solutions are organized into five comprehensive bundles,

each addressing specific pharmaceutical compliance challenges.

Core Bundle

Foundation Compliance & Governance Platform

The foundation every pharmaceutical company needs. AI governance, regulatory intelligence, data integrity, and privacy protection in one integrated platform.

The foundation every pharmaceutical company needs. AI governance, regulatory intelligence,

data integrity, and privacy protection in one integrated platform.

The foundation every pharmaceutical company needs.

AI governance, regulatory intelligence, data integrity, and

privacy protection in one integrated platform.

Key Platforms:

  • ComplianceIQ: AI/ML readiness & governance (48-hour assessments)

  • AskRexi: Multi-jurisdictional compliance (19 jurisdictions, 600+ rules)

  • ClinoxisCore: Data integrity & governance (GxP compliance)

  • DataGovernanceIQ: Data privacy & security (GDPR, HIPAA, CCPA)

  • ComplianceIQ: AI/ML readiness & governance
    (48-hour assessments)

  • AskRexi: Multi-jurisdictional compliance (19 jurisdictions,
    600+ rules)

  • ClinoxisCore: Data integrity & governance (GxP compliance)

  • DataGovernanceIQ: Data privacy & security (GDPR,
    HIPAA, CCPA)

Use Cases:

✓ AI/ML project compliance assessment

✓ Multi-jurisdictional regulatory compliance


✓ Data integrity and audit trail management


✓ Privacy compliance (GDPR, HIPAA, CCPA)

Ideal for: All pharmaceutical companies—the essential foundation for all operations

Perfect for: Pre-IND through Phase 3 biotech companies who

need enterprise compliance without enterprise complexity

Perfect for: Pre-IND through Phase 3 biotech companies

who need enterprise compliance without enterprise complexity

Commercial OS Bundle

Complete Commercial Operations Platform

One platform with 8 integrated use cases. From HCP engagement to revenue optimization. Switch on what you need, when you need it.

One platform with 8 integrated use cases. From HCP engagement to revenue optimization.

Switch on what you need, when you need it.

One platform with 8 integrated use cases. From HCP

engagement to revenue optimization. Switch on what you need,

when you need it.

8 Integrated Use Cases:

  • HCP720IQ: HCP engagement & 720-degree view

  • SpendIQ: Payment transparency & Sunshine Act

  • PromoIQ: Promotional compliance (FDA 21 CFR Part 202)

  • CommercialIQ: Commercial operations management

  • RevenueIQ: Sales forecasting & revenue optimization

  • ExecuteIQ: Business intelligence (From Vision to Execution)

  • Patient360IQ: Patient services & volunteer management

  • GrowthIQ: Business development & strategic partnerships

Use Cases:

✓ HCP engagement and relationship management


✓ Sunshine Act compliance and payment tracking


✓ Promotional content compliance validation


✓ Sales forecasting and revenue optimization


✓ Business intelligence and market analysis


✓ Patient support and volunteer management


✓ Strategic partnerships and business development

Ideal for: All pharmaceutical companies—the essential foundation for all operations

Perfect for: Pre-IND through Phase 3 biotech companies who

need enterprise compliance without enterprise complexity

Perfect for: Pre-IND through Phase 3 biotech companies

who need enterprise compliance without enterprise complexity

Manufacturing Bundle

Manufacturing & Supply Chain Compliance Platform

Manufacturing & Supply Chain

Compliance Platform

End-to-end manufacturing compliance. From CAPA to supply chain, complete GMP compliance and quality management in one platform.

End-to-end manufacturing compliance. From CAPA to supply chain, complete GMP compliance

and quality management in one platform.

End-to-end manufacturing compliance. From CAPA to

supply chain, complete GMP compliance and quality

management in one platform.

Key Platforms:

  • RegIQ: CAPA management & eCTD (self-validating for FDA)

  • Manufacturing Compliance: GMP validation & quality systems

  • Supply Chain: Supply chain optimization & logistics

  • Quality Management: Quality system automation & validation

  • Batch Records: Electronic batch record management

  • ComplianceIQ: AI/ML readiness & governance
    (48-hour assessments)

  • AskRexi: Multi-jurisdictional compliance (19 jurisdictions,
    600+ rules)

  • ClinoxisCore: Data integrity & governance (GxP compliance)

  • DataGovernanceIQ: Data privacy & security (GDPR,
    HIPAA, CCPA)

Use Cases:

✓ CAPA management and deviation triage


✓ GMP compliance and validation


✓ eCTD generation and FDA submission


✓ Supply chain optimization and inventory management


✓ Quality system management and batch record review

Ideal for: All pharmaceutical companies—the essential foundation for all operations

Perfect for: Pre-IND through Phase 3 biotech companies who

need enterprise compliance without enterprise complexity

Perfect for: Pre-IND through Phase 3 biotech companies

who need enterprise compliance without enterprise complexity

Medical Affairs Bundle

Medical Affairs & HCP Engagement Platform

Complete medical affairs operations. KOL management, HCP engagement, patient services, and medical literature intelligence in one platform.

Complete medical affairs operations. KOL management, HCP engagement, patient services, and

medical literature intelligence in one platform.

Complete medical affairs operations. KOL management,

HCP engagement, patient services, and medical literature

intelligence in one platform.

Key Platforms:

  • Medical Affairs Platform: KOL relationship management

  • HCP720IQ: HCP management & 720-degree view

  • Patient360IQ: Patient services & voluntary management

  • Literature Intelligence: Medical literature review & synthesis

  • ComplianceIQ: AI/ML readiness & governance
    (48-hour assessments)

  • AskRexi: Multi-jurisdictional compliance (19 jurisdictions,
    600+ rules)

  • ClinoxisCore: Data integrity & governance (GxP compliance)

  • DataGovernanceIQ: Data privacy & security (GDPR,
    HIPAA, CCPA)

Use Cases:

✓ KOL relationship management and engagement

✓ HCP engagement and 720-degree view

✓ Patient support and voluntary management

✓ Medical literature review and publication management

Ideal for: Medical affairs teams, MSLs, medical directors, KOL management

Perfect for: Pre-IND through Phase 3 biotech companies who

need enterprise compliance without enterprise complexity

Perfect for: Pre-IND through Phase 3 biotech companies

who need enterprise compliance without enterprise complexity

Clinical Bundle

Clinical Development & Trial Management Platform

Clinical Development & Trial

Management Platform

Complete clinical development platform. From protocol design through patient engagement, complete clinical trial management and data analytics.

Complete clinical development platform. From protocol design through patient engagement,

omplete clinical trial management and data analytics.

Complete clinical development platform. From protocol

design through patient engagement, complete clinical trial

management and data analytics.

Key Platforms:

  • Clinical Trial Management: Trial operations & protocol validation

  • Clinical Data Hub: Patient data management & GCP compliance

  • Pharmacovigilance: Adverse event reporting & signal detection

  • RWD Analytics: Real-world data analytics & outcomes research

  • Patient Engagement: DEI program design & trial recruitment

  • ComplianceIQ: AI/ML readiness & governance
    (48-hour assessments)

  • AskRexi: Multi-jurisdictional compliance (19 jurisdictions,
    600+ rules)

  • ClinoxisCore: Data integrity & governance (GxP compliance)

  • DataGovernanceIQ: Data privacy & security (GDPR,
    HIPAA, CCPA)

Use Cases:

✓Clinical trial management and site management

✓Clinical data management and patient matching

✓Adverse event reporting and safety monitoring

✓Real-world evidence generation and outcomes research

✓Patient engagement and diversity optimization


Ideal for: Clinical operations teams, CROs, clinical research organizations

Perfect for: Pre-IND through Phase 3 biotech companies who

need enterprise compliance without enterprise complexity

Perfect for: Pre-IND through Phase 3 biotech companies

who need enterprise compliance without enterprise complexity

Mix and Match Solutions

All TFives solutions integrate seamlessly. Start with one bundle, add others as your needs evolve.

All systems communicate natively—near-zero integration costs.

Example Combinations

Biotech Startup

Core Bundle + Clinical Bundle

Commercial Pharma

Core Bundle + Commercial OS Bundle

Full Lifecycle Company

All 5 Bundles (Complete Platform)

CDMO

Core Bundle + Manufacturing Bundle