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.
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.
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.
Tailored AI solutions for every stakeholder in the clinical trial ecosystem.
Running global, multi-site trials requiring strict regulatory control and operational efficiency.
Learn moreManaging diverse client portfolios with consistent quality and delivery commitments.
Learn moreSeeking operational scale at compliance without adding headcount.
Learn moreRun enterprise-grade trials with a lean team. AI agents fill capability gaps without the overhead.
Learn moreStay ahead of evolving regulations with AI-powered compliance monitoring and submission preparation.
Learn moreNavigate complex device trial requirements with specialized agents trained on medical device regulations.
Learn moreFour steps. Every action supervised. Every outcome documented.
Monitor clinical systems and ingest data from protocols, queries, safety reports, documents, and sites.
Identify patterns, flag risks, draft outputs, and trigger approved actions within defined governance guardrails.
Perform approved actions across Clinical Trial Operations, such as resolving queries, populating fields, and more.
Every action is logged with full context. Human reviewers retain approval authority at every step.
Purpose-built AI agents that execute real clinical trial work — from study startup to regulatory submission.
Role: Study Startup Accelerator
Goal: Cut startup timelines by 50%
Role: Quality Guardian
Goal: Zero critical data findings
Role: Early Phase Specialist
Goal: Faster FIH to Phase 2 transition
Role: Data Manager
Goal: 90% auto-query resolution
Role: Stats Programmer
Goal: 70% programming automation
Role: Medical Writer
Goal: 3x faster document drafting
Role: Site Assistant
Goal: 50% site burden reduction
Role: Enrollment Optimizer
Goal: 2x enrollment velocity
Built for the complexity of clinical trials. Ready on day one.
21 CFR Part 11, ICH-GCP, and SOC 2 Type II. Immutable audit logs and role-based access built in.
Purpose-built for clinical workflows — data management, safety, monitoring, and regulatory submissions.
Connects with EDC, CTMS, safety systems, eTMF, and imaging platforms. No rip-and-replace.
Agents run across the full trial lifecycle with full visibility, human oversight, and audit-ready trails.
Validated templates, change-controlled deployment, and role-based permissions — no coding required.
21 CFR Part 11, ICH-GCP, and SOC 2 Type II. Immutable audit logs and role-based access built in.
Purpose-built for clinical workflows — data management, safety, monitoring, and regulatory submissions.
Connects with EDC, CTMS, safety systems, eTMF, and imaging platforms. No rip-and-replace.
Agents run across the full trial lifecycle with full visibility, human oversight, and audit-ready trails.
Validated templates, change-controlled deployment, and role-based permissions — no coding required.
A unified platform that connects every phase of your clinical trial — from protocol design through final submission — with intelligent AI agents working in concert.
Deploy specialized AI agents without writing a single line of code. Configure, orchestrate, and monitor your autonomous workforce through an intuitive visual interface.
Every agent operates within a regulatory-first framework. Full 21 CFR Part 11 compliance, GxP validation, and complete audit trails built into the foundation.
Across every function of clinical operations, AI agents reduce the execution burden on your team.
Protocol review, risk identification, feasibility assessments.
Site activation tracking, enrollment monitoring, communication workflows.
Query triage and resolution support, edit check review, data quality monitoring.
Case intake support, narrative drafting, coding assistance, regulatory reporting preparation.
Deviation tracking, CAPA workflows, inspection readiness support.
Document classification, eTMF completeness checks, submission package preparation.
Analytics detect issues. Dashboards visualise risk.
Every role in clinical operations gets a dedicated AI partner.
Oversee your entire trial portfolio with real-time AI-powered insights and automated risk alerts.
Learn more →Automate edit checks, resolve queries faster, and achieve cleaner databases with AI-driven CDM.
Learn more →Accelerate statistical programming with automated SDTM/ADaM mappings and TLF generation.
Learn more →Draft regulatory documents 3x faster with AI-assisted authoring and automated cross-referencing.
Learn more →Reduce administrative workload with AI copilots that handle source verification and query management.
Learn more →Continuous risk-based monitoring with real-time compliance dashboards and automated audit preparation.
Learn more →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.
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.
Join the leading pharmaceutical companies already transforming their clinical operations with Maxis AI.