CLINICAL INTELLIGENCE

AI-assisted proficiency for biometrics and biostatistics operations.

Ten services across two layers, plus a custom route when your bottleneck fits none of them. We engage through workflow corridors: one bounded slice of your operation at a time, piloted, evidenced and signed off before the next begins. Each service lists what you provide, what you receive, and who signs off; nothing is quoted before the scope is understood.

Acceleration Sprint Biometrics Modernization CertusAI · Axiom AI Coding Operations Catalyst Agents Spotfire and Visualization SAS Ecosystem SAS Viya · LSAF to CA Agent Infrastructure Metadata, Governance, Cloud Custom AI Development

THE CORRIDOR MAP · WHERE WE OPERATE · CLICK A CORRIDOR

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First proof corridor, TLF QC evidence acceleration, demonstrated on synthetic data in the Evidence Room.

WHERE EVERY ENGAGEMENT STARTS

Validated Automation Review. One workflow, fixed scope, typically two to four weeks. Every service below is entered through it, after a free 30-minute fit call.

Book a fit call

LAYER 1 · OPERATIONAL INTELLIGENCE

The daily work, made faster and auditable

FLAGSHIP PROGRAM · TYPICALLY 12 TO 24 WEEKS

Biometrics Acceleration Sprint

Discovery-led modernization of an active regulated environment: baseline, design under change control, implement the modules discovery justifies, measure against the baseline. Not staff augmentation, not a platform migration.

Phases: Alignment and scope · Architecture and workflow discovery · Controlled design · Implementation · Measurement and transition

Request a scoped proposal

YOU PROVIDE

Environment access, SOPs and change-control process, one SME, and the studies in scope.

YOU RECEIVE

Sprint Charter, Architecture Blueprint, Opportunity Matrix, Risk Map, Design Spec, Validation Plan with traceability matrix, Impact Report.

SIGN-OFF

Your change-control board approves every implementation module before it is built; your lead programmer accepts the Impact Report.

SDTM · ADaM · TLF · QC · SUBMISSION

Clinical Biometrics Modernization

Controlled improvement of the programming operation inside your governance: derivation standardization, spec-to-code traceability, TLF production engineering, QC cycle-time mapping and defect root cause, pre-validation automation, CDISC hardening with Pinnacle 21 run continuously, FDA and EMA submission hardening, Part 11 posture review.

We do not: replace your CRO, disrupt active studies, or introduce uncontrolled change.

YOU PROVIDE

Specifications, the SAP, macro libraries, current QC records and a timeline.

YOU RECEIVE

Standardized derivations and shells, reproducible pipelines, QC automation, audit-ready documentation, baseline-to-result metrics, a prioritized roadmap.

SIGN-OFF

Named reviewer per deliverable; every enhancement documented and change-managed to your framework.

NAMED METHOD · TLF QC

CertusAI: automated TLF comparison and validation

Structured tables are compared deterministically against expected output; figures and free text are flagged for a person. Four phases: template analysis, parser configuration, validation rules, pilot and deployment.

PROVIDE

Output shells, a QC sample set, the comparison SOP.

RECEIVE

Parser and rules in your SAS or R estate, a comparison record per output, validation evidence.

SIGN-OFF

QC lead accepts each rule set; a person clears every flagged figure.

NAMED METHOD · SDTM MAPPING

Axiom AI: AI-assisted SDTM and CDISC transformation

The model proposes mappings for unspecified source variables; controlled terminology and conformance rules check them; your programmer accepts or rejects each one. Four phases: data ecosystem mapping, AI-assisted mapping, human validation, ongoing partnership.

PROVIDE

Source metadata, the mapping spec, CT version, read access.

RECEIVE

Proposed mappings with rationale, conformance pre-checks, an accepted-mapping record, the code.

SIGN-OFF

Named programmer per domain; the record shows proposed, changed, accepted.

NEW OFFERING · IDE-NATIVE · FOUR PACKAGES

Coding Operations and Automation

Governed AI coding operations for clinical programming teams: migration parity validation, agent skills inside the IDE your programmers already use, R integration with environment qualification, and metadata lineage. Methods built in current sponsor-side work; no client named, no client figure borrowed.

See the four packages

Migration Parity Validation

Dataset equivalence between legacy and target: SAS 9.4 or LSAF to Viya, SAS to R.

Governed Agent Shelf

Skills in the IDE: job launch, run triage, log diagnosis, provisioning, controlled backups.

R Integration and Qualification

R inside the SAS estate, with a GxP environment qualification framework.

Metadata Lineage

Rename impact, dataset dependency and derivation answers over your programs and metadata.

CLINICAL AGENTS · 90 TO 120 DAYS · PILOT, CORE, SUITE

Catalyst Clinical Agents

Four agent capabilities, each built against your schemas and deployed in your VPC or on premise. Start with one capability on one or two studies. Every recommendation requires human review; compliance and readiness checks follow deterministic rules over structured data.

Designed for validation under GAMP 5, with Part 11 audit trail controls in the design. Validation documents are listed on the About page as they exist.

Data quality monitoring

Watches EDC and source streams, ranks anomalies, drafts queries for review.

Standards compliance checks

Validates source against the SDTM spec and CT continuously; Pinnacle 21 pre-checks.

Submission readiness tracking

One view over TLF QC, SDTM outputs and narratives; tracks FDA and EMA guidance changes.

Protocol question answering

Queryable protocol layer, deviation risk register, eligibility confirmations for sites.

LAYER 2 · PLATFORM INTELLIGENCE

The estate your studies run on

SPOTFIRE · SAS VISUAL ANALYTICS · R SHINY · D3.JS · HIGHCHARTS

Clinical Visualization and Spotfire Intelligence

HIGHLIGHT · PATIENT PROFILE DEVELOPMENT

Interactive patient profiles that unify the SDTM domains by subject: demographics, exposure, adverse events, labs and concomitant medications on one timeline, self-service for medical monitors and reviewers, generated per study from your standards.

Sponsor-controlled visualization infrastructure that turns SDTM and ADaM data into oversight. Spotfire first, because it is the clinical industry standard, on premise or self-hosted with GxP access control. SAS Visual Analytics where the estate runs on Viya. Custom third-party builds in D3.js or Highcharts when a dashboard needs full control of rendering and interaction. CDISC-aligned ingestion with Pinnacle 21 in the pipeline; protocol-specific dashboards (endpoints, enrollment, AE clusters, lab shifts, PK/PD, RBQM site risk, DMC reporting); near-real-time refresh from RAVE, Veeva or Oracle; AI-augmented signal detection under validation.

Phases: Infrastructure stabilization 4 to 10 weeks · Intelligence acceleration 6 to 14 weeks · Managed clinical intelligence, ongoing LIMITED AVAILABILITY

YOU PROVIDE

Current Spotfire posture, EDC and data-transfer specs, protocol endpoints, RBQM plan, hosting constraints.

YOU RECEIVE

A validated server environment you own, metadata-driven ETL, protocol dashboards, signal alerts, DMC-ready reporting, governance documentation.

SIGN-OFF

Clinical operations and biometrics leads accept each dashboard against its spec; signal rules are validated before they alert.

01 · PATIENT PROFILE · SDTM domains unified on one subject timelineSYNTHETIC DATA

02 · LAB ANALYSIS · shift and excursion review across visitsSYNTHETIC DATA

03 · OVERSIGHT · enrollment and site risk on one screenSYNTHETIC DATA

04 · SAFETY SCATTER · quadrant review with flags a monitor can act onSYNTHETIC DATA

Four layouts from the visualization practice, cycling automatically, all rendered from synthetic data. These are illustrative renderings of layout and content, not product screenshots; the delivered work runs in Spotfire, SAS Visual Analytics, R Shiny, D3.js or Highcharts inside your environment, against your standards.

SAS 9.4 · GRID · MACROS · EDC PIPELINES

SAS Ecosystem Optimization

Six pillars for the SAS estate behind submissions: infrastructure and Grid tuning, a version-controlled global macro library, continuous CDISC checks with Pinnacle 21 eCLI, automated EDC pipelines with audit trails, environment health monitoring, disaster recovery with a defined RTO.

Phases: Ecosystem audit 2 to 6 weeks · Architecture and build 6 to 14 weeks · Validation and deploy 4 to 10 weeks · Optimize retainer LIMITED AVAILABILITY

YOU PROVIDE

Server and Grid access, the macro inventory, batch schedules, current compliance gaps.

YOU RECEIVE

A tuned environment, a consolidated validated macro framework, CDISC pipeline, EDC integration, monitoring dashboards, DR runbook, IQ/OQ/PQ evidence.

SIGN-OFF

Your SAS administrator and validation lead accept each pillar; the macro library ships with a change record.

VIYA · CAS · LSAF TO CLINICAL ACCELERATION · 9.4 COEXISTENCE

SAS Viya Implementation

Migration readiness and modernization without disrupting active trials: 9.4 audit of code, macros and Grid topology; CAS architecture on Azure or AWS with GxP controls; macro modernization for the CAS engine; Part 11 and GAMP 5 continuity with an IQ/OQ/PQ framework; role-specific enablement; hybrid 9.4 and Viya coexistence. Includes migration from LSAF to SAS Clinical Acceleration: repository structure, job execution, audit-trail continuity, and dataset parity validated before cut-over.

Phases: Discovery 2 to 8 weeks · Architect and pilot 8 to 16 weeks · Production 16 to 28 weeks. Architecture, code modernization and training are delivered with your engineering and IT teams.

YOU PROVIDE

The program inventory, both environments, regulatory obligations, the current validation state.

YOU RECEIVE

Risk-weighted roadmap, pilot migration with benchmarks, migrated programs with an equivalence report each, coexistence plan, validation package.

SIGN-OFF

Equivalence accepted by your validation lead before cut-over; nothing moves to production without it.

AZURE OPENAI · AWS BEDROCK · IN YOUR TENANCY

Governed LLM and Agent Infrastructure

The architecture clinical agents run on, built inside your Azure or AWS tenancy: a model gateway under your identity system, orchestration wiring between agents and your platforms, prompt and output logging into your audit trail, and an evaluation harness that gates anything from reaching production. Built once, reused by Catalyst, custom agents and every automation that follows.

Why it comes first: the security review asks where the model runs before it asks what the model does.

YOU PROVIDE

Your cloud tenancy, identity system, security policy and model allowlist.

YOU RECEIVE

A reference architecture deployed in your tenancy, gateway and logging configuration, orchestration patterns, the evaluation harness, a runbook.

SIGN-OFF

Your security and IT leads accept the architecture; no model endpoint goes live outside your allowlist.

SAS METADATA · PROVISIONING · AZURE OR AWS

Metadata, Governance and Clinical Cloud

SAS Management Console administration, automated study provisioning, lineage tracking, and client-owned cloud architecture with compliance built in. Delivered as part of a Sprint or an Ecosystem engagement, or standalone when the estate is the bottleneck.

YOU PROVIDE

Metadata server access, provisioning SOP, cloud tenancy you own, security policy.

YOU RECEIVE

Provisioning automation, lineage reports, a reference architecture in your tenancy, access-control documentation.

SIGN-OFF

Your IT and QA leads accept the architecture; provisioning runs only under your identity system.

CUSTOM · DEVELOPMENT, IMPLEMENTATION, DEPLOYMENT

Custom AI for quantitative sciences

When the bottleneck fits no named service, INNOVIZZ scopes a bespoke build: development against your workflow, implementation inside your estate, deployment under change control with validation documentation alongside the code. The entry is the same fit call and Validated Automation Review, and the four rules apply without exception.

Bring the workflow

YOU PROVIDE

The workflow, the environment, acceptance criteria, and a named reviewer.

YOU RECEIVE

A scoped design, the build with source code, validation documentation, training, hand-over. No platform fee follows.

SIGN-OFF

Your change-control board approves the design; your reviewer accepts each deliverable against the criteria.

Environments we work in

We adapt to your estate. We do not ask you to adopt ours.

SAS 9.4 / Grid SAS Viya / CAS LSAF R / Python Spotfire R Shiny Pinnacle 21 eCLI Medidata RAVE · Veeva · Oracle Azure · AWS · on premise

Where We Are Not a Fit

Patient-level data uploaded to a vendor platform.

Unreviewed model output in a submission deliverable.

CRO replacement, FSP staffing or full study outsourcing.

Cosmetic dashboard work with no governance behind it.

How is an engagement priced?

Every engagement is scoped to the study, the systems involved and the timeline, so we quote after a short scoping conversation. You receive a written proposal with deliverables, milestones and acceptance criteria.

Request a scoped proposal