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The AI Agent Workforce

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The First AI Workforce for Clinical Trials — Built for Regulatory Control, Speed and Quality

Powered by agentic AI in life sciences, Maxis delivers supervised execution across regulated clinical workflows. Purpose built for Sponsors, CROs & Site Networks.

Increase execution capacity Maintain governance Scale without linear headcount growth
3,500+ trials supported across sponsors & CROs
GxP-aligned 21 CFR Part 11 ready Human-in-the-loop governance No system replacement
Regulatory Compliance
Regulatory Filing Agent
21 CFR Part 11 & GxP validated
All checks passed
HIPAA Compliance
Audit Trail
Electronic Signatures
Study Startup
AI Startup Accelerator
5 sites activated this week
Protocol approved
IRB submission filed
Site activation in progress
SITES ONLINE
US EU UK JP +2
Agent Status Live
AI Data Quality Monitor
Processing 12,847 data points
87% Data quality score

Trusted by Leading Pharmaceutical Companies

Pfizer Novartis AstraZeneca Merck Roche Sanofi GSK Johnson & Johnson Pfizer Novartis AstraZeneca Merck Roche Sanofi GSK Johnson & Johnson

The Problem

The Execution Gap

Clinical trials have visibility. They lack execution capacity.

“Digital platforms improved monitoring. They did not increase throughput.”

“Teams detect risks earlier. They still resolve them manually.”

“Clinical development remains labor-bound.”

Maxis introduces an AI Workforce that addresses these gaps.


What We Do

Deploying AI Agents That Execute Clinical Trial Work

Maxis AI deploys an AI workforce in clinical trials through supervised AI agents to execute clinical trial work across study design, conduct, risk & data management to regulatory reporting — with demonstrated cost efficiency in defined clinical workflows.

Actions Logged
Traceable Logic
Transparent Decision Logic
Compliance Ready
Who We Serve

Who Maxis AI Supports

Tailored AI solutions for every stakeholder in the clinical trial ecosystem.

🏢

Pharmaceutical Sponsors

Running global, multi-site trials requiring strict regulatory control and operational efficiency.

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🔬

Contract Research Orgs

Managing diverse client portfolios with consistent quality and delivery commitments.

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🏥

Site Networks

Seeking operational scale at compliance without adding headcount.

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🧬

Biotech Startups

Run enterprise-grade trials with a lean team. AI agents fill capability gaps without the overhead.

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📋

Regulatory Affairs

Stay ahead of evolving regulations with AI-powered compliance monitoring and submission preparation.

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💊

Medical Devices

Navigate complex device trial requirements with specialized agents trained on medical device regulations.

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How It Works

How Maxis AI Works

Four steps. Every action supervised. Every outcome documented.

01

Observe

Monitor clinical systems and ingest data from protocols, queries, safety reports, documents, and sites.

02

Reason

Identify patterns, flag risks, draft outputs, and trigger approved actions within defined governance guardrails.

03

Execute

Perform approved actions across Clinical Trial Operations, such as resolving queries, populating fields, and more.

04

Document

Every action is logged with full context. Human reviewers retain approval authority at every step.

Meet Your AI Workforce

Autonomous Agents.
Real Results.

Purpose-built AI agents that execute real clinical trial work — from study startup to regulatory submission.

🚀
AI Accelerated Startup & IRB
Study Startup
Accelerate IRB submissions and site activation with autonomous document preparation and tracking.

Role: Study Startup Accelerator

Goal: Cut startup timelines by 50%

📊
AI Data Quality & RBQM Hub
Data Management
Real-time risk-based quality monitoring with automated signal detection and issue resolution.

Role: Quality Guardian

Goal: Zero critical data findings

Phase 1 Accelerator
Early Phase
Streamline first-in-human trials with intelligent protocol design and safety monitoring.

Role: Early Phase Specialist

Goal: Faster FIH to Phase 2 transition

🗃️
AI-Driven CDM
CRO Services
Autonomous clinical data management with intelligent edit checks, query resolution, and database locks.

Role: Data Manager

Goal: 90% auto-query resolution

📈
AI Statistical Programming
Biostatistics
Automated SDTM/ADaM programming, TLF generation, and CDISC compliance verification.

Role: Stats Programmer

Goal: 70% programming automation

📝
AI Medical Writing
Regulatory
Generate regulatory documents, CSRs, and submission-ready narratives with AI-assisted authoring.

Role: Medical Writer

Goal: 3x faster document drafting

🤝
AI-Site Copilot
Site Networks
Empower research sites with AI-assisted source verification, query management, and compliance tools.

Role: Site Assistant

Goal: 50% site burden reduction

🎯
AI Enrollment Booster
Patient Recruitment
Predictive enrollment analytics and AI-driven patient matching to accelerate recruitment timelines.

Role: Enrollment Optimizer

Goal: 2x enrollment velocity

Capabilities

Core Capabilities

Built for the complexity of clinical trials. Ready on day one.

Security & Compliance

Enterprise-grade governance designed for GxP environments. All agent activity aligns with 21 CFR Part 11, ICH-GCP, and SOC 2 Type II requirements.

  • Role-based access controls
  • Encrypted data handling
  • Immutable audit logs
  • Built-in inspection-ready traceability

Verticalized AI Agents

Pre-trained agents purpose-built for clinical trial workflows, designed with protocol awareness, clinical context, and regulatory expectations.

  • Data management
  • Safety & pharmacovigilance
  • Site monitoring
  • Risk & quality management
  • Regulatory submissions

Integration Layer

Connects seamlessly with your existing clinical systems, enabling coordinated execution in your technology stack.

  • Integrates with EDC, CTMS, safety systems, imaging platforms, and eTMF
  • Routes tasks across systems automatically
  • Escalates exceptions based on pre-approved logic
  • No rip-and-replace required

Continuous Supervised Execution

AI agents operate continuously across the trial lifecycle, accelerating workflows while maintaining governance and human oversight.

  • Measured task execution
  • Full visibility into agent activity
  • Audit-ready decision trails

No-Code Deployment

Deploy and configure agents without coding, within controlled environments aligned to your SOPs, security, and IT governance.

  • Validated configuration templates
  • Role-based permissions
  • Change-controlled deployment
  • Secure, scalable implementation
The Platform

End-to-End AI Orchestration

📋

Study Design to Regulatory Reporting

A unified platform that connects every phase of your clinical trial — from protocol design through final submission — with intelligent AI agents working in concert.

  • Automated protocol optimization
  • Real-time study monitoring dashboards
  • Integrated regulatory intelligence
  • End-to-end audit trail
🤖

No-Code AI Agents

Deploy specialized AI agents without writing a single line of code. Configure, orchestrate, and monitor your autonomous workforce through an intuitive visual interface.

  • Visual agent builder
  • Pre-built agent templates
  • Real-time orchestration dashboard
  • Human-in-the-loop controls
🔒

Built for Compliance

Every agent operates within a regulatory-first framework. Full 21 CFR Part 11 compliance, GxP validation, and complete audit trails built into the foundation.

  • 21 CFR Part 11 compliant
  • GxP validated workflows
  • SOC 2 Type II certified
  • HIPAA compliant data handling
Impact Areas

Where AI Agents Deliver Impact

Across every function of clinical operations, AI agents reduce the execution burden on your team.

Study Design & Feasibility

Protocol review, risk identification, feasibility assessments.

Site & Patient Operations

Site activation tracking, enrollment monitoring, communication workflows.

Data Management

Query triage and resolution support, edit check review, data quality monitoring.

Safety & Pharmacovigilance

Case intake support, narrative drafting, coding assistance, regulatory reporting preparation.

Risk & Quality Management

Deviation tracking, CAPA workflows, inspection readiness support.

Regulatory Submissions

Document classification, eTMF completeness checks, submission package preparation.

Before Maxis

Insight identifies.

Analytics detect issues. Dashboards visualize risk.

Monitoring flags the issue
Team is notified
Manual resolution begins
Days or weeks pass
With Maxis

Execution resolves.

Maxis performs the work required to resolve it.

Agent identifies the issue
Resolution is drafted and logged
Action executed within guardrails
Resolved in minutes, not weeks
By Role

AI That Works for You

Every role in clinical operations gets a dedicated AI partner.

👤

Clinical Operations Lead

Oversee your entire trial portfolio with real-time AI-powered insights and automated risk alerts.

Learn more →
🔍

Data Manager

Automate edit checks, resolve queries faster, and achieve cleaner databases with AI-driven CDM.

Learn more →
📊

Biostatistician

Accelerate statistical programming with automated SDTM/ADaM mappings and TLF generation.

Learn more →
📝

Medical Writer

Draft regulatory documents 3x faster with AI-assisted authoring and automated cross-referencing.

Learn more →
⚕️

Site Coordinator

Reduce administrative workload with AI copilots that handle source verification and query management.

Learn more →
🛡️

Quality & Compliance

Continuous risk-based monitoring with real-time compliance dashboards and automated audit preparation.

Learn more →

0
Trials Supported
0%
Cost Reduction
0
Enterprise Clients

Maxis AI has transformed how we run clinical trials. What used to take weeks now happens in hours — with better quality and full regulatory compliance.

VP
VP of Clinical Operations
Top 10 Global Pharmaceutical Company
FAQ

Common Questions

Everything you need to know about deploying an AI workforce in your clinical operations.

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. We focus 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 have demonstrated: reduced repetitive manual effort, improved workflow consistency, and increased execution throughput. Measured impact depends on workflow scope and deployment context.

Ready to Deploy Your
AI Workforce?

Join the leading pharmaceutical companies already transforming their clinical operations with Maxis AI.