- Practical AI implementation.
- Measurable operational improvement.
- Honest execution.
Clinical Agentic AI
Your clinical data.
Working for you.
Designed for pharma, biotech, and CRO biometrics teams
Precision-deployed AI agents for clinical biometrics.
Your biometrics team is running manual quality checks, chasing CDISC compliance gaps, and compiling submission packages by hand. Four purpose-built AI agents eliminate those bottlenecks inside your infrastructure over 90 to 120 days, built by a team with 13+ years of hands-on clinical biometrics experience across Fortune 500 pharma.
The Shift
Stop managing clinical data manually.
Start deploying agents that do it for you.
What your team does today
What Catalyst replaces it with
Manual data quality reviews that take days and still miss anomalies
SCOUT monitors your EDC streams 24/7 and flags issues before your team opens the data
CDISC compliance checks run at the end of the cycle, catching errors too late
MERIDIAN validates SDTM compliance continuously, catching domain deviations before TLF builds begin
Submission readiness tracked in spreadsheets across 6 departments
SENTINEL provides a single, real-time submission readiness view with regulatory update monitoring
Protocol deviations discovered during site audits, weeks after they occur
GUARDIAN flags protocol risks proactively, before they become deviations
Generic enterprise platforms that require multi-quarter onboarding and IT migration
Deploys inside your existing infrastructure within 90 to 120 days. No platform migration. No lock-in. Your data stays yours
Vendor teams who learn your domain on your budget
13+ years of clinical programming depth across TEVA, Celgene/BMS, and PPD embedded into every agent from day one
ROI promised in a slide deck. Measured never
ROI tracked and reported within 120 days. If the numbers do not prove out, you see it first
The Four Catalyst Agents
Each agent eliminates
a specific bottleneck.
Data Quality Intelligence
SCOUT
Continuous Clinical Data Monitoring
Watches your EDC and source data streams 24/7. SCOUT identifies anomalies, out-of-range values, implausible patterns, and protocol compliance signals before they reach downstream analysis. Replaces reactive monitoring with proactive intelligence, stopping deviation risk before it becomes a deviation.
Incoming EDC loads, data transfers, scheduled review windows
Priority-ranked anomaly reports, auto-drafted data queries, deviation risk flags
CDISC Compliance Automation
MERIDIAN
SDTM and CDISC Compliance Monitor
Validates your incoming source data against CDISC SDTM mapping specifications and controlled terminology standards. MERIDIAN flags domain-level deviations before the TLF and dataset build cycle begins, reducing rework cycles and preventing submission blockers from forming downstream.
Source data updates, SDTM spec changes, new data transfers
Domain compliance deviation reports, Pinnacle 21 pre-check summaries, submission scoring
Submission Readiness Command
SENTINEL
Regulatory Submission Coordinator
Aggregates your TLF quality reports, SDTM validation outputs, and clinical narratives into a single unified submission readiness view. SENTINEL monitors FDA/EMA guidance updates for impact on active programs and alerts your team to gaps before they become submission blockers.
TLF QC reports, SDTM validation outputs, regulatory guidance publications
Submission readiness dashboard, gap tracker, cross-functional action lists
Protocol Intelligence
GUARDIAN
Deviation Prevention and Protocol Compliance
Protocol-aware deviation prevention agent powered by AI document intelligence. GUARDIAN ingests your study protocols and builds a queryable knowledge layer. GUARDIAN proactively monitors active study operations for data patterns that signal deviation risk, delivers plain-language protocol guidance to site staff before deviations occur, and maintains a real-time study-specific deviation risk register.
Incoming patient data, visit records, eligibility checks, SCOUT anomaly alerts
Deviation risk register, plain-language site alerts, I/E eligibility confirmations
Deployment Model
Live in 90 to 120 days.
1
Weeks 1 to 2
Workflow Audit
Map your biometrics processes, identify the three highest-friction bottlenecks, confirm which agents and integration points deliver fastest ROI for your study portfolio.
2
Weeks 3 to 6
Agent Build
Every agent is custom-built against your actual data schemas, EDC configuration, and DM system format. Clinical domain expertise is layered in directly by the INNOVIZZ team, not a configuration wizard.
3
Weeks 7 to 10
Validation
GxP-aligned validation documentation prepared in parallel with system testing. Each agent is tested against representative study data before any live deployment.
4
Weeks 12 to 16
Live + Handover
Agents deployed in your environment. Team training delivered. 30-day monitored support window. You own the infrastructure. No ongoing platform fee.
Technology Architecture
Each agent is built on
proven AI infrastructure.
Every Catalyst agent is purpose-built using enterprise AI models, custom RAG pipelines, and domain-specific clinical logic developed from 13+ years of hands-on biometrics programming experience.
SCOUT
powered by
Enterprise Model Layer
Each agent is powered by enterprise-grade language models with clinical domain context, CDISC standards, and regulatory terminology specific to your therapeutic area.
MERIDIAN
powered by
Custom RAG Pipelines
Your protocols, mapping specs, SDTM standards, and regulatory guidance are ingested into secure, private vector stores. Agents retrieve and reason over your actual data.
SENTINEL
powered by
Client Infrastructure
Agents deploy within your existing environment. AWS, Azure, or on-premise. Your clinical data never leaves your infrastructure. No cloud platform migration required.
GUARDIAN
powered by
GxP Validation Layer
Full audit trails, IQ/OQ/PQ documentation, 21 CFR Part 11 aligned controls, and electronic signature integration. Every agent action is logged, traceable, and audit-ready.
Compliance Posture
GxP-aligned by design.
21 CFR Part 11
Full audit trail on all agent actions and outputs. User authentication, access logging, and electronic signature controls included.
GAMP 5 Category 4
IQ/OQ/PQ validation documentation package prepared by INNOVIZZ and included in Tier 2 and Tier 3 engagements.
Your Infrastructure
Agents deploy in your VPC or cloud environment. Your study data never leaves your security perimeter. No platform data sharing.
Human-in-the-Loop
Every agent recommendation requires human review before action. Catalyst is designed for advisory outputs that augment your team, not replace oversight.
Controlled Outputs for QC-Critical Workflows
MERIDIAN and SENTINEL outputs are grounded in structured data and specification documents, not generative inference. QC-critical outputs follow deterministic rules with full audit trails.
HIPAA / GDPR Ready
Data residency controls, role-based access, and processing agreements aligned to HIPAA and GDPR requirements across all engagement tiers.
Engagement Structure
Start with one agent.
Scale to the full suite.
Catalyst Pilot
One Agent. One Problem. Solved.
The fastest path to proving ROI. Choose the single agent that eliminates your most pressing bottleneck and deploy it against 1-2 active studies.
1 custom Catalyst agent
1 to 2 active studies
8 to 12-week deployment
Basic validation documentation
30-day post-deployment support
Catalyst Core
Multi-Agent Biometrics Coverage.
Deploy 2 to 3 agents with full GxP validation across up to 5 studies. The most common entry point for mid-size pharma and CROs with active portfolios.
2 to 3 custom Catalyst agents
Up to 5 active studies
12 to 16-week deployment
Full GxP validation package
Technology architecture documentation included
30-day monitored support window
Catalyst Suite
Full Portfolio Intelligence.
All four agents deployed across your full study portfolio on-premise or VPC deployment, and an enterprise-grade validation package.
All 4 Catalyst agents
Full study portfolio scope
16 to 20-week deployment
On-premise or VPC deployment
Full platform integration and expansion roadmap
Quarterly optimization reviews
All tiers: no pre-built templates, no platform onboarding, no per-seat licensing. Every agent is purpose-built for your environment. Pricing available on request.
Next Step
Start with a
60-minute workflow audit.
Every Catalyst engagement begins with a no-cost session where INNOVIZZ maps your clinical biometrics workflow, identifies your three highest-friction bottlenecks, and confirms which agents will eliminate them. No platform demo. No slide deck. Clinical experts with 13+ years of biometrics depth running the engagement from day one.