INNOVIZZ - Clinical Intelligence Consulting
Clinical Intelligence Consulting

The Clinical AI
Partner
That Ships

CROs sell hours. Platform vendors sell subscriptions. INNOVIZZ deploys clinical-grade AI systems engineered for your environment with ongoing partnership. Led by a former Principal Technical Architect with Fortune 500 pharmaceutical and global CRO experience.

Powered by AMICA Framework 5-Pillar Clinical AI Implementation Methodology
Fortune 500 Pharma Experience
5,000+ User Environments
99% Infrastructure Uptime
60% Faster Review Cycles
The AI Deployment Gap

Your AI Investment Isn’t Deploying

Clinical organizations invest millions in AI platforms yet struggle to deploy systems that transform operations. The gap is not technology. It is implementation expertise that understands both the science and the infrastructure.

Platform Lock-In

AI platform vendors require 6 to 12 months of configuration, ongoing SaaS subscriptions, and organizational transformation. You pay indefinitely but never own the infrastructure.

Compliance Gaps

Generic AI consultants and technology vendors lack pharmaceutical domain expertise in CDISC, 21 CFR Part 11, and GxP validation, creating regulatory risks that surface at the worst possible time.

Manual Dependency

Your biometrics team remains trapped in manual SAS workflows and spreadsheet tracking despite millions invested in "digital transformation" because the consultants who sold the strategy cannot execute the deployment.

Deployment Architecture, Not Platform Sales

We are not a CRO selling expert hours. We are not a platform vendor requiring lock-in contracts. We are not a staffing provider filling seats. We are deployment architects who implement AI-driven clinical operations engineered for your infrastructure, integrated with your workflows, and supported through ongoing partnership.

Backed by 13+ years inside pharmaceutical operations — not observing from the outside — INNOVIZZ bridges the gap between AI capability and clinical reality. We understand CDISC standards, 21 CFR Part 11 compliance, SAS Viya migration, and the operational bottlenecks that keep biometrics directors awake at night.

The result: AI systems that pass regulatory scrutiny, integrate with your existing technology stack across multiple platforms, and deliver measurable ROI. No vendor lock-in. Continuous optimization. Performance committed.

Why Clinical Leaders Choose INNOVIZZ

AMICA Framework Methodology Proprietary 5-pillar assessment (AI, Measurement, Implementation, Compliance, Acceleration)
13+ Years Domain Expertise CDISC, ADaM, SDTM, SAS Viya CAS, Spotfire, Medidata Rave, Pinnacle 21
Multi-Technology Integration SAS, Python, R/RShiny, Spotfire, DJANGO, and cloud platforms unified under one engagement
Deep Integration, No Lock-In Systems engineered for your environment with ongoing support. No platform dependencies. No vendor switching costs.
Practitioner-Led Architecture Built by engineers who have administered SAS Grid for 5,000+ users at 99% uptime, not sales teams
Phased Delivery Model Discovery in weeks, pilot validation in months, production deployment with full GxP compliance and ongoing optimization
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Clinical Intelligence Services

Ten core capabilities spanning the full clinical data lifecycle, from infrastructure architecture to regulatory submission. AI handles volume; human expertise handles judgment. Every workflow includes human-in-the-loop validation where clinical decisions require it.

01

AI-Powered Clinical Data Review

Field-tested across Phase 2-4 trials: 60% faster data review cycles and 92% anomaly detection accuracy. AI handles pattern detection at scale; clinical experts make the judgment calls.

  • Predictive anomaly detection with human-in-the-loop review
  • Agentic AI for automated TLF production (70% time reduction)
  • GxP-validated AI/ML deployment with full audit trail
EXPLORE AI REVIEW →
02

CDISC Data Operations & Compliance

Manual data workflows are costing you months and exposing you to compliance risk. We deliver automated, validated pipelines: 100% error-free ETL processing, $30K+ vendor cost savings per study, and 60% faster validation via Pinnacle 21 eCLI.

  • SDTM/ADaM standards implementation and conversion
  • Pinnacle 21 eCLI deployment for continuous compliance
  • Define.xml generation and controlled terminology management
AUTOMATE OPERATIONS →
03

Biostatistics & Programming Automation

Your programmers are burning hours on repetitive statistical workflows that should be automated. SAS macro optimization proven to improve efficiency from 68% to 92%, QC cycle times cut by 45%, and 1,200+ staff hours reclaimed annually across SAS, Python, and R.

  • Global SAS macro library development and optimization
  • Multi-technology workflows (SAS, Python, R unified)
  • Automated TLF and ADaM/SDTM dataset creation
ACCELERATE SUBMISSIONS →
04

SAS Viya Migration & Architecture

Legacy SAS environments are holding your biometrics team hostage. We architect cloud-native Viya CAS migrations at enterprise scale: 5,000+ user environments, full 21 CFR Part 11 compliance maintained throughout.

  • SAS Viya CAS engine evaluation and pilot programs
  • Legacy macro modernization for Viya compatibility
  • Migration roadmap with performance benchmarking
MODERNIZE SAS →
05

Multi-Platform Clinical Visualization

Your teams are drowning in disconnected dashboards and static reports. We deploy unified visualization ecosystems across Spotfire, RShiny, Power BI, and custom portals: 8 enterprise solutions delivered in one year, 5,000+ users, 70% performance gains.

  • Spotfire Center of Excellence deployment and mentorship
  • RShiny dashboards for complex statistical analysis
  • Real-time trial monitoring and anomaly alerting
UNIFY YOUR DASHBOARDS →
06

SAS Metadata & Data Governance

Eliminate metadata chaos with automated SAS Management Console administration and metadata-driven quality validation. Macro efficiency improved from 68% to 92%, data discovery reduced from weeks to minutes, coding errors cut by 75%.

  • SAS Management Console administration and optimization
  • Automated study configuration and library provisioning
  • Data governance framework and lineage tracking
MASTER METADATA →
07

Biometrics Issue Management

Replace spreadsheet tracking with intelligent issue management. AI handles categorization and routing at scale; team leads retain override authority. Validated for 2,000+ issues across global operations with 50% faster resolution.

  • AI-assisted categorization with human override capability
  • 21 CFR Part 11 compliant audit trail documentation
  • Cross-functional visibility for clinical operations teams
ELIMINATE CHAOS →
08

Automated Submission Readiness

Shift from last-minute submission scrambles to continuous regulatory readiness. Pinnacle 21 eCLI automation delivers 60% faster validation with real-time gap detection against evolving FDA and EMA guidance.

  • Continuous CDISC compliance monitoring with automated flagging
  • Automated define.xml and reviewer's guide generation
  • FDA/EMA/PMDA submission package quality assurance
AUTOMATE SUBMISSIONS →
09

Clinical Cloud Infrastructure

On-premise infrastructure is slowing your pipeline and inflating costs. We architect secure, compliant cloud environments (Azure/AWS) with 99% uptime during transitions: pharma-grade security, complete data ownership, zero vendor lock-in.

  • Azure/AWS pharma-grade architecture design
  • 21 CFR Part 11, HIPAA, GxP compliance built-in
  • Client-owned infrastructure, no platform lock-in
BUILD SECURE CLOUD →
10

Patient-Centric Data Intelligence

Medical monitors wait days for profiles that should take minutes. We deploy interactive patient profile systems unifying all SDTM domains by subject: self-service access for clinical teams, with medical professionals retaining interpretive sign-off.

  • Unified cross-domain view: AE, CM, LB, VS, MH, EX, EG, DS by subject
  • Interactive timelines with synchronized clinical events
  • On-demand PDF/RTF generation with sign-off workflow
TRANSFORM PATIENT ACCESS →

INNOVIZZ PROPRIETARY FRAMEWORK

CertusAI™

Your programmers and QC programmers spend weeks manually comparing TLF outputs cell by cell in Excel. It is tedious, error-prone, and consumes thousands of staff hours per submission cycle. CertusAI automates the comparison of structured table outputs against QC outputs, flagging discrepancies with tolerance-based numeric matching and source data traceability. Engineered for your specific RTF templates and validation workflows.

Template Analysis

Map your standard RTF/output templates, table structures, and numeric precision requirements

Parser Configuration

Engineer custom parsers for your specific template formats, merged cells, footnote conventions

Validation Rules

Define tolerance thresholds, rounding rules, and acceptable variance based on your SOPs

Pilot & Deployment

Test on representative studies, validate accuracy, deploy with GxP documentation and ongoing support

The Manual QC Bottleneck

Human-in-the-Loop by Design

Weeks

Manual Comparison

1000s

Cells Per Study

Tables

Automated Comparison

Figures

Flagged for Review

INNOVIZZ Proprietary Framework

Axiom AI™

Intelligent SDTM/CDISC Transformation

SDTM mapping and CDISC transformation remain one of clinical data operations' most labor-intensive processes. Organizations either hire expensive specialists, outsource to CROs billing by the hour, or struggle with rigid platforms that don't fit their data ecosystem. Axiom AI is INNOVIZZ's proprietary framework for intelligent, automated CDISC transformation, configured for each client's unique source data structures and regulatory requirements.

1

Data Ecosystem Mapping

Assess your EDC, source data structures, existing CDISC assets, and transformation workflows

2

AI-Assisted Mapping

Axiom AI suggests domain classification and variable mappings; CDISC experts review and validate

3

Human Validation

Edge cases flagged for expert review; final SDTM outputs validated by qualified personnel

4

Ongoing Partnership

Production support, CDISC standard updates, continuous optimization as your portfolio evolves

Explore Axiom AI for Your Environment →
The SDTM Transformation Challenge
6-12
Months Manual SDTM
$150K+
Specialist Salary/Year
AI-Driven
Domain Classification
Automated
Variable Mapping
AI Suggests, Experts Validate Axiom AI accelerates the tedious work: domain classification, variable mapping, controlled terminology alignment. But CDISC expertise cannot be fully automated. Non-standard source data, therapeutic area edge cases, and sponsor-specific conventions require human judgment. AI handles volume; your CDISC experts handle exceptions. Final validation sign-off remains with qualified personnel.

Your Clinical Challenge.
Our Engineering Commitment.

Every clinical operation has unique complexities that standard service categories cannot fully address. Proprietary data ecosystems, legacy system integrations, therapeutic area-specific workflows, organizational constraints that no off-the-shelf framework anticipates. We understand this because we have lived it.

If your requirement falls outside the ten core capabilities above, or requires a combination of disciplines that spans multiple service areas, INNOVIZZ welcomes the conversation. We scope, architect, and deliver custom clinical AI solutions with the same rigor, regulatory compliance, and practitioner-led methodology that defines every engagement.

Initial consultations are complimentary. No obligation. No sales pitch. Just a technical conversation about what is possible.

Custom Engagement Examples

Hybrid Technology Integrations

Connecting proprietary EDC systems, in-house biostatistics tools, or non-standard data sources into unified AI-powered pipelines

Therapeutic Area-Specific AI

Oncology, rare disease, or CNS trial workflows with domain-specific validation logic and regulatory nuance

Multi-Vendor Consolidation

Replacing fragmented vendor ecosystems with a single, integrated clinical intelligence layer across your organization

Regulatory-First AI Pilots

Proof-of-concept deployments designed from inception to satisfy FDA, EMA, or PMDA inspection readiness

Legacy System Modernization

Phased migration strategies for entrenched SAS, Oracle Clinical, or Medidata RAVE environments with zero operational disruption

The INNOVIZZ Commitment Every custom engagement follows the same AMICA methodology: rigorous assessment, transparent scoping, phased delivery with validation gates, and complete knowledge transfer. If we determine a requirement falls outside our core competencies, we will tell you directly and recommend the right partner. We would rather earn long-term trust than win a single engagement.

Proven Expertise

Built on Clinical-Grade Foundations

Fortune 500 Pedigree

Principal-level clinical analytics architecture experience across Fortune 500 pharmaceutical and global CRO organizations

AMICA Framework

Proprietary 5-pillar clinical AI readiness methodology: AI, Measurement, Implementation, Compliance, Acceleration

13+ Years

Pharmaceutical and CRO domain expertise across clinical data operations, biometrics programming, and regulatory submissions

GxP Compliance

21 CFR Part 11 validation, GAMP 5, IQ/OQ/PQ execution, and regulatory-ready AI deployment documentation

CDISC Mastery

End-to-end SDTM, ADaM, define.xml, annotated CRF, Pinnacle 21, and submission workflow expertise

Multi-Platform Architecture

Unified integration across SAS, SAS Viya CAS, Python, R/RShiny, Spotfire, DJANGO, Databricks, and cloud platforms

Proprietary Frameworks

CertusAI™ automated TLF validation and Axiom AI™ intelligent CDISC transformation, engineered for each client's environment

Proven Results

60% faster review cycles, 92% anomaly accuracy, 55% batch processing reduction, $30K+ vendor cost savings per study

Transform Clinical Operations with Practitioner-Led AI

Discover how INNOVIZZ deploys regulatory-compliant AI systems engineered for your environment, built by practitioners who have architected and managed these systems at enterprise scale. From initial discovery through production deployment and ongoing optimization, we partner with your team to deliver measurable outcomes.

Schedule Consultation