Clinical Consulting

Clinical Spotfire
Intelligence™

Executive-Grade Clinical Visualization Infrastructure

Clinical trials are not delayed because data is missing. They are delayed because insight arrives too late.

INNOVIZZ architects secure, sponsor-controlled Spotfire environments that transform SDTM and ADaM data into continuous operational intelligence. The result: compressed risk detection timelines, strengthened regulatory posture, and submission readiness stabilized from Day 1.

This is not dashboard configuration.
It is clinical intelligence infrastructure.
Schedule Assessment Explore Capabilities
On-Premise or Secure Cloud Deployment
The Challenge

The Risk Most Sponsors Underestimate

Most sponsors already use Spotfire. Yet the majority operate well below its strategic potential.

  • Dashboards remain template-bound.
  • Refresh cycles are batch-dependent.
  • Signal detection is reactive, not predictive.
  • Visualization logic is CRO-controlled.
  • Infrastructure is not aligned to ICH E6(R3) expectations.

The consequence is measurable. Operational blind spots. Late-stage firefighting. Compressed submission windows. Regulatory exposure that compounds with every delayed insight cycle.

ICH E6(R3) now establishes risk-based quality management as the backbone of GCP compliance, explicitly endorsing centralized monitoring, analytics dashboards, and continuous data governance.

Static visualization is no longer a limitation. It is a compliance liability.

In modern development programs, even single-digit week acceleration between data lock and submission materially impacts asset value.

Visualization is no longer cosmetic. It is strategic risk control.

What We Deploy

Five Layers of Clinical Intelligence

From infrastructure architecture to AI-augmented signal detection. Each layer builds on the prior. Each is engineered for your environment.

Primary Differentiator

On-Premise First. Infrastructure Sovereignty Always.

Many pharmaceutical organizations are not cloud-agnostic. And they should not be forced into a model that compromises data sovereignty for vendor convenience.

Cloud-native deployment (Azure or AWS) is available when appropriate. But infrastructure sovereignty always remains with the sponsor. Your data. Your environment. Your control.

  • On-premise Spotfire Server deployment and validation
  • Internal network isolation with sponsor-controlled environments
  • GxP-aligned access controls and role-based governance
  • Regulatory-compliant disaster recovery configuration
  • Multi-study scalable architecture
  • Performance optimization for enterprise data volumes

This is the capability that SaaS-first vendors cannot deliver. And it is the capability that ICH E6(R3) increasingly demands.

02

CDISC-Aligned Data Engineering

Visualization without structured data architecture is unstable. We engineer the pipeline that makes every dashboard defensible.

  • Automated SDTM ingestion workflows
  • ADaM mapping and derivation support
  • Pinnacle 21 integration and continuous validation
  • Metadata-driven ETL orchestration
  • Submission-grade data structuring
  • Continuous compliance monitoring
03

Protocol-Specific Dashboards

We do not deploy generic templates. We architect dashboards driven by your protocol. Every metric is intentional. Every view is defensible.

  • Endpoint progression tracking
  • Enrollment velocity heatmaps
  • Adverse event signal clustering
  • Lab shift anomaly detection
  • PK/PD visual intelligence
  • RBQM site risk scoring
  • DMC-ready executive reporting layers
04

Near-Real-Time Oversight

We eliminate visualization latency. Spotfire becomes a living operational oversight layer, not a retrospective reporting tool.

  • API-driven data ingestion
  • Automated refresh orchestration
  • EDC system integration (RAVE, Veeva, Oracle)
  • Continuous anomaly triggers
  • Signal-based alert workflows
  • Role-specific intelligence views
05

AI-Augmented Signal Detection

Where appropriate, we integrate predictive intelligence. Visualization evolves from reporting into operational foresight.

  • Predictive enrollment slowdown modeling
  • Site outlier detection
  • Adverse event cluster identification
  • Risk scoring algorithms
  • Adaptive anomaly detection

Deployed within INNOVIZZ's AMICA governance methodology. GxP validation aligned.

Engagement Model

Three Phases to Operational Intelligence

Every engagement follows the AMICA methodology. Structured. Phased. Measurable at every gate.

Phase 1

Infrastructure Stabilization

4 to 8 Weeks
  • On-premise or secure cloud deployment
  • Server configuration and validation
  • Data pipeline implementation
  • Baseline clinical dashboards
  • Governance and compliance alignment
Phase 2

Intelligence Acceleration

6 to 12 Weeks
  • Endpoint-specific dashboard refinement
  • AI signal integration
  • Risk scoring and modeling
  • DMC intelligence and executive reporting
Phase 3

Managed Clinical Intelligence

Ongoing
  • Continuous optimization and model refinement
  • Multi-study expansion
  • Performance tuning
  • Submission acceleration support
Fit Assessment

Who This Is For

Biotech Sponsors

Phase II and III programs requiring infrastructure control and data sovereignty

Clinical Operations Leaders

Demanding earlier risk detection and continuous oversight capability

Heads of Biometrics

Seeking RBQM-aligned visualization that meets ICH E6(R3) expectations

Sponsors Reclaiming Control

Moving visualization logic from CRO-managed templates to sponsor-owned infrastructure

On-Premise Requirements

Organizations with hybrid or on-premise infrastructure mandates

CROs Seeking Differentiation

Building intelligence depth as a competitive advantage

If your objective is cosmetic dashboards, this is not the right engagement.

If your objective is operational stability, regulatory alignment, and earlier risk detection, it is.

The INNOVIZZ Standard
"When you partner with INNOVIZZ, you don't just get better. You gain capabilities your competitors cannot buy, build, or borrow."

Clinical visualization is not a design decision.
It is a strategic control decision.

Executive Consultation

Book a Clinical Spotfire
Intelligence Assessment

A confidential 30-minute executive review covering:

Current Spotfire infrastructure posture CDISC ingestion maturity Refresh latency exposure Signal detection readiness RBQM alignment AI augmentation feasibility
Schedule Your Assessment

No generic audit. A strategic evaluation aligned to your protocol and operational goals.