Implementation & Validation Services

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.

10x

Faster Than Traditional Consulting

$0

Upfront Risk - Pay for Outcomes Only

100%*

Outcome-Based Pricing

Not Your Typical Consulting Firm

We're an advisory firm with a technology advantage

Traditional Consulting

Staff Augmentation

Billing by hours, headcount, and time & materials

Generic Frameworks

Off-the-shelf methodologies applied to most organizations

Long Timelines

6-12 month engagements with unclear ROI

You Own the Risk

Pay regardless of whether outcomes are achieved

tfives Advisory Model

Strategic Advisory

C-suite partnerships focused on business outcomes

Proprietary Accelerators

IP-protected frameworks that compress timelines by 10x

Rapid Delivery

Working solutions in weeks, not months

We share the risk with outcome-based pricing*

No outcome, no fee - Outcome-based pricing*

Why tfives Is Different

We're not a traditional consulting firm or staffing company. We're strategic advisors with proprietary technology that delivers outcomes-based delivery.

IP-Led Advisory

Our proprietary accelerators—Stencil Framework, AskRexi, Clinoxis—enable 10x faster delivery than traditional consulting.

  • • Patent-pending Stencil Agent Framework
  • • Drop-in Compliance (AskRexi)
  • • API Marketplace (Clinoxis)
  • • BRD to MVP in 6 hours

Outcome-Based Model

We only get paid when you achieve the specific, measurable outcomes we define together. No results, no payment—ever.

  • • minimal upfront investment
  • • Payment on validated outcomes
  • • Outcome-based pricing*
  • • We own all the risk

Regulated Industries

Deep expertise in Life Sciences and Healthcare with built-in compliance frameworks for FDA, HIPAA, EMA, and PMDA.

  • • Compliance-first architecture
  • • Audit-ready documentation
  • • Regulatory intelligence integration
  • • 21 CFR Part 11 by default

The FIVES Framework: Our Core Methodology

The Problem: 70% of pharma AI projects fail because compliance is treated as an afterthought.

The Solution: The FIVES Framework designs for success across five critical dimensions simultaneously from Day 1.

The 5 Dimensions of results-focused approach

F

FIT

Risk-Based Validation

GAMP 5 proportional to risk—no excessive rigor

I

INTEGRITY

Trustworthy Systems

Auditor-ready explainability, data lineage, bias detection

V

VALIDATION

Inspection Certainty

FDA audit strategies based on real-world findings

E

ECONOMICS

Compliance ROI

Significant reduction in time-to-validation

S

SCALE

Growth Infrastructure

Infrastructure designed for 10x growth

Traditional Approach

Method: Build → Rework for Compliance → Hope for Scale

Timeline: 10+ months

Result: 70% Failure Rate

FIVES Framework

Method: Design for F+I+V+E+S simultaneously

Timeline: 8 weeks to verified deployment

Result: High success rate* (based on typical implementations)

All our assessments and advisory services are powered by the FIVES Framework.

Get Your FIVES Assessment →

Advisory Solutions

Strategic engagements backed by proprietary accelerators

Business-Technology Alignment

30-day assessment to identify and close the gap between business strategy and technology execution.

Learn More →

Agentic AI Implementation

Strategy to production in 90 days using our Stencil Agent Framework and governance toolkit.

Learn More →

Legacy Modernization

Risk-free migration to modern architecture with zero downtime using our ATLASE methodology.

Learn More →

AI Governance & Policy

Compliance-first AI strategy for regulated industries with audit-ready frameworks.

Learn More →

Looking for detailed platform implementation services?

View Implementation Services →

Legacy Modernization

Risk-Free Migration to Modern Architecture

Strategic guidance to modernize legacy systems without business disruption, using our ATLASE methodology to preserve existing investments.

Our Approach:

  • • Assessment of current architecture and dependencies
  • • Phased migration strategy with zero-downtime approach
  • • ATLASE framework to amplify existing investments
  • • Change management and team enablement

Risk:

Zero Downtime Guarantee

Model:

Success-Based Pricing

Start Migration Planning

Vibe Coding

Rapid development methodology that delivers working software in hours, not weeks. Our agentic approach to coding compresses traditional development cycles by 10x.

Key Features:

  • • Agentic AI code generation
  • • Automated testing and validation
  • • Real-time deployment pipelines
  • • Continuous iteration cycles

Delivery Model:

24-Hour MVP

Guarantee:

Working Software

Explore Vibe Coding

Business-Technology Alignment

30-Day Strategic Assessment & Roadmap

30-day assessment to identify and close the gap between business strategy and technology execution. Comprehensive AI assessment across all five critical dimensions (FIT, INTEGRITY, VALIDATION, ECONOMICS, SCALE) with target 4+ scores.

What You Get:

  • • Gap analysis across FIT, INTEGRITY, VALIDATION, ECONOMICS, SCALE
  • • AskRexi compliance audit (global jurisdictions, comprehensive rule coverage)
  • • Current state analysis across technology, data, and processes
  • • Quantified gaps and misalignments with business objectives
  • • Prioritized roadmap with ROI projections
  • • Executive presentation with board-ready recommendations

Timeline:

30 Days

Investment:

Outcome-Based

Outcome-based pricing—pay only for results

Request Assessment

Agentic AI Implementation

Strategy to Production in 90 Days

End-to-end advisory for implementing compliant, ROI-positive AI systems using our proprietary Stencil Agent Framework and governance toolkit.

Accelerators Included:

  • • Stencil Framework - Pre-built compliance templates
  • • Agent Orchestration - Proven architecture patterns
  • • Governance Toolkit - AI policy and risk frameworks
  • • Working MVP in 6 hours (vs 6 months traditional)

Timeline:

90 Days

Guarantee:

Working Production System

Explore AI Advisory

AI Governance & Policy

Compliance-First AI Strategy

Develop comprehensive AI governance frameworks for regulated industries, ensuring innovation without regulatory risk.

Deliverables:

  • • AI policy and governance framework (FDA/HIPAA/EMA)
  • • Risk assessment and mitigation strategies
  • • Explainability and transparency protocols
  • • Audit preparation and documentation

Focus:

Life Sciences & Healthcare

Outcome:

Audit-Ready Framework

Build Governance

Discovery to Launch+

End-to-End AI Implementation

End-to-end AI implementation from target identification through commercial deployment and beyond. Compliance-first solutions at every stage with 310+ production-ready APIs across 40+ systems.

Coverage:

  • • PreClinical/Early Discovery Sciences
  • • Clinical Development
  • • Manufacturing & Supply Chain
  • • Commercial Operations
  • • Patient Safety & Pharmacovigilance

Timeline:

Phased Delivery

Approach:

Compliance-First

Explore Discovery to Launch+

Our Technology Accelerators

Proprietary IP that enables 10x faster delivery with built-in compliance

Stencil Framework

Patent-Pending

Domain-specific agent templates that enable rapid AI deployment with built-in compliance. Transform BRD to working MVP in 6 hours.

Capabilities:

  • • Pre-built compliance stencils
  • • Auto-generated audit trails
  • • Inheritance-based customization

AskRexi

Drop-in Compliance

Compliance-as-a-Service covering every facet of Life Sciences from molecule to market with real-time monitoring.

Coverage:

  • • FDA/EMA/PMDA intelligence
  • • Real-time compliance monitoring
  • • Automated documentation
Explore AskRexi →

Clinoxis

API Marketplace

Enterprise API marketplace that maximizes ROI from technical assets through reusability and governance.

Features:

  • • Cataloged reusable components
  • • Version control & governance
  • • Usage analytics & ROI tracking

These accelerators are included in all advisory engagements. Traditional consulting firms charge extra for tools. We include our IP to deliver faster outcomes at no additional cost.

Build > Talk Principle

Why we're not a traditional consulting or staffing firm

Traditional Consulting/Staffing

Sprint planning meetings - Hours of discussions about what to build

Story point estimation - Guessing how long things will take

PowerPoint demonstrations - Showing slides instead of working software

Retrospective discussions - Talking about what went wrong

Bill by hour/headcount - More people = more revenue

2-4 weeks per cycle

tfives Agentic Delivery

Deploy working software - Show, don't tell - real functionality

Measure real user behavior - Data-driven validation, not opinions

Adapt based on usage data - Let users guide the next iteration

Deploy next iteration - Continuous improvement loops

Bill on outcomes only - We win when you win

4-6 hours per cycle

Rapid MVP Generation Flow

From business requirements to working software in one day

1

BRD to Stencils

  • • Parse business requirements
  • • Generate domain stencils
  • • Create inheritance hierarchies
  • • Map compliance rules

30 minutes

2

Agent Orchestration

  • • Select specialized agents
  • • Configure workflows
  • • Establish communication
  • • Define success metrics

45 minutes

3

Synthetic Data Generation

  • • Extract metadata patterns
  • • Generate test datasets
  • • Create user scenarios
  • • Populate workflows

1 hour

4

Working MVP

  • • Deploy to staging
  • • Enable user access
  • • Capture usage data
  • • Video narrative ready

2-4 hours

Example: Clinical Trial Management System

Input BRD

"Track patient enrollment across multiple sites. Ensure FDA compliance for data collection. Real-time dashboard for study managers. Integration with existing CRM system."

Generated Stencils

  • • Patient.stencil (21CFR11)
  • • Site.stencil (GCP)
  • • Dashboard.stencil (RBAC)
  • • CRMIntegration.stencil (API)
  • • AuditTrail.stencil (FDA)

Working MVP

✓ Patient enrollment forms
✓ Site management interface
✓ Real-time dashboard
✓ CRM data sync
✓ Compliance audit logs

6 Hours: BRD → Working Software

Non-Intrusive Validation

Real user interaction with actual software, not mockups or prototypes

Real User Interaction

Users interact with actual software, not mockups or prototypes

Behavior-Based Metrics

Measure what users do, not what they say they'll do

Continuous Adaptation

Software evolves based on usage patterns, not assumptions

Video Narrative Model

Show, Don't Tell - Record actual user workflows, not presentation slides

Show, Don't Tell

Record actual user workflows, not presentation slides

Real-Time Demonstrations

Walk through working features with live data

Iterative Storytelling

Each iteration builds on previous working version

What We Don't Do

Eliminated activities replaced with direct outcomes

Eliminated Activities

Sprint planning for AI-buildable features

Story point estimation sessions

PowerPoint demo presentations

Process retrospectives vs. outcome focus

User acceptance testing of obvious features

Replaced With

Direct user interaction with working software

Real-time usage metrics and adaptation

Video narratives of actual workflows

Outcome measurement and iteration

Continuous deployment and validation

Our Engagement Model

How we partner with you for results-focused approach

1

Define Outcomes

We co-create specific, measurable business outcomes with your leadership team

2

Deploy Accelerators

Apply our proprietary frameworks and technology to compress delivery timelines

3

Measure Results

Track progress against defined metrics with full transparency and regular checkpoints

4

Pay on Success

Payment triggered only when agreed outcomes are achieved and validated

Proven Track Record

Real results from real engagements

Significant

Technology Value Delivered

Multiple

MVPs Built, Multiple in Production

100%*

Success Rate* (based on typical implementations)

Our Guarantee

No Outcome, No Fee - No Exceptions

100%

Outcome Guarantee

0%

Upfront Investment

6 Hours

To Working MVP

Ready to Transform Your Business With minimal risk?

Schedule a consultation to discuss your challenges and how our accelerators can deliver outcomes-based delivery in weeks, not months.

No commitment required • Free initial assessment • Outcome-based engagement only