The First AI WORKFORCE for Clinical Trials
Watch how supervised AI agents change the shape of cycle times, coverage, and oversight — without changing your core systems.
Trusted across sponsors, CROs & site networks
Years industry experience
Clinical studies
Domain & AI experts
Pharma/LS focus
Renewal rate
AI agents
Orchestrations
System integrations
Visibility is solved. Execution Capacity is the gap.
Digital platforms improved monitoring. They did not increase throughput. Maxis introduces an AI Workforce that converts signals into governed execution.
Signal coverage without Maxis AI
Detection coverage
Resolution capacity
With Maxis AI Workforce
Detection coverage
Resolution capacity
Structural pressure across clinical development.
A new operating model is required to scale execution without proportional headcount growth.
An AI Workforce, working alongside your teams.
Supervised
Core
Where days become hours.
Across the workflows that bottleneck most studies, supervised execution compresses the cycle without removing oversight.
Workflow turnaround — before vs. after Maxis AI
A supervised execution layer across regulated workflows.
System of Records
EDC · CTMS · eTMF · safety · imaging
System of Records
EDC · CTMS · eTMF · safety · imaging
System of Records
EDC · CTMS · eTMF · safety · imaging
System of Records
EDC · CTMS · eTMF · safety · imaging
Observability
Every agent step visible in real time across workflows.
Audit Trail
Immutable, timestamped record of every action and decision.
Explainability
Clear rationale for every output and recommendation.
Reproducibility
Identical inputs produce identical, verifiable results.
Six steps. Every one, traceable.
A single, supervised execution loop — visible end to end.
Observe
Monitor clinical systems and ingest data from protocols, queries, safety reports, documents, and sites.
Reason
Identify patterns, flag risks, draft outputs, and determine next steps within approved workflow logic.
Execute
Perform approved actions across defined clinical workflows.
Validate
Human reviewers retain approval authority where required.
Log
Every action is documented with context and traceability.
Escalate
Exceptions are routed to the appropriate human or function.
The organizations executing modern clinical trials.
Sponsors
Running global, multi-site trials requiring regulatory control, operational consistency, and timeline predictability.
CROs
Managing diverse client portfolios with quality, delivery, and margin expectations.
Site Networks
Seeking operational scale and workflow clarity without adding unnecessary manual burden.
Backed by Enterprise-grade Security and Scale.
Maxis AI operates within the standards regulated clinical environments require — independently audited, fully traceable across every framework that matters.
Quality Management
Certified quality management system
Information Security
Information security management standard
Trust Services
Audited security, availability & confidentiality
Data Protection
European data privacy & protection compliance
Regulatory Practices
Good Practice frameworks across clinical ops
US FDA — eRecords
Electronic records & electronic signatures
US FDA — QSR
Quality System Regulation for medical software
Good Clinical Practice
International clinical research standards
EU — Computerised Systems
EU GMP guidance for computerised systems
Controls built into every layer.
The execution model is governed by design — not bolted on after.
Role-based access controls
Granular permissions across teams and workflows
Encrypted data handling
At-rest and in-transit encryption end-to-end
Immutable audit logs
Every action recorded with full context
Inspection-ready traceability
Reviewable activity history on demand
Targeted impact across the trial lifecycle.
Study Design & Feasibility
Protocol review, risk identification, feasibility assessments.
Data Management
Query triage, edit check review, reconciliation, and data quality monitoring.
Safety & Pharmacovigilance
Case intake support, narrative drafting, coding assistance, and reporting preparation.
Risk & Quality Management
Deviation tracking, CAPA workflows, oversight coordination, and inspection readiness.
Regulatory Submissions
Document classification, eTMF completeness checks, and submission package preparation.
Site & Patient Operations
Site activation tracking, enrollment monitoring, and communication workflows.
The platform behind the workforce.
Six purpose-built layers — scroll to see each one stack into place, from the agents you interact with down to the compliance foundation governing every action.
Agent Layer
Purpose-built AI companions for specific clinical programming tasks.
Core Components
Orchestration Layer
Purpose-built AI companions for specific clinical programming tasks.
Core Components
Context Layer
Purpose-built AI companions for specific clinical programming tasks.
Core Components
Foundation Model Layer
Purpose-built AI companions for specific clinical programming tasks.
Core Components
Data Integration Layer
Purpose-built AI companions for specific clinical programming tasks.
Core Components
Verification & Compliance Layer
Purpose-built AI companions for specific clinical programming tasks.
Core Components
Loved by teams that scale fast.
Real stories from teams who streamlined workflows and delivered more with less.
Building globally competitive clinical research in Africa requires more than infrastructure — it requires coordinated, scalable execution. Leveraging Maxis AI, we see a clear opportunity to streamline fragmented regulatory processes and accelerate trial starts.
Dr. Tariro Makadzange, MD, DPhil
CEO, Africa Clinical Research Network (ACRN)
Insights from the frontline.
AI-Enabled Risk-Based Monitoring: Enhanced Clinical Trial Oversight
The way we monitor clinical trials is undergoing a transformation.
Read more
A Governance Framework for Agentic AI in GxP Environments
Controls, audit trails, validation, and reviewer escalation across the agent lifecycle.
Read more
Phase 1 Trial: First Patient In <100 Days. Under $400K.
How a Boston oncology biotech ran a first-in-human Phase 1 with 45% faster startup, 2–3× enrollment conversion, and 50% faster database lock — at under $400K versus a $2–5M traditional CRO bid.
Read moreSee Where Maxis AI Is Heading Next
SCDM Annual Conference 2026
Workshop and live agent walk-through.
Read more
DIA Global Annual Meeting 2026
Maxis AI panel: 'Governed AI in Submissions.'
Read more
SCOPE Summit 2026 — Orlando
Visit us at Booth 312 for live agentic CDM demos.
Read moreAll you need to know.
Common questions about deploying governed agentic AI in regulated clinical environments.
Yes, when deployed within a governed framework. Maxis AI aligns platform operations with GxP principles, 21 CFR Part 11 requirements, and established validation practices.
Maxis AI applies agentic AI through a supervised execution model. AI agents perform defined clinical workflows under sponsor-approved permissions and governance checkpoints. Every action remains traceable, reviewable, and aligned to regulated standards.
Yes. The AI Workforce integrates into existing electronic systems and workflows. It does not require core system replacement.
Analytics platforms identify risks and generate insights. The Maxis AI Workforce performs the operational work required to resolve them. Maxis focuses on execution capacity, not dashboards.
No. The AI Workforce operates under defined supervision. It reduces repetitive workload while preserving clinical judgment and regulatory accountability.
Organizations can expect reduced repetitive manual effort, improved workflow consistency, and increased execution throughput. Measured impact depends on workflow scope and deployment context.
Explore our AI Workforce Platform
See how AI agents are transforming study startup, data management, oversight, and regulatory submissions.