CTRENAISSANCE®

Clinical Data Analytics

Purpose-built clinical data technology for life sciences R&D. From data ingestion to regulatory reporting.

For over two decades, Maxis AI (formerly MaxisIT) has helped pharma, biotech, and medical device companies manage clinical trialdata with integrated, automated, and compliant technology. The CTRenaissance®platform and its suite of modules continue to power thousands of clinical trialsacross the globe.

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3,300+
Trials in Cloud
40+
Dashboards
22
eClinical Systems
100%
Renewal rate

Clinical Trials Oversight System

Real-timeportfolio visibility. Study-level and cross-study dashboards with automated KPItracking and risk alerts.
What it does

Portfolio-level andstudy-level dashboards with automated KPI tracking

Enrollment tracking, siteperformance monitoring, and milestone alerting

Risk assessment tools withthreshold-based alerts across studies and sites

No-codeconfiguration with integration across EDC, CTMS, and eClinical systems

Why it matters

Reusable components accelerate study startup

Automated lineage tracking eliminates manual metadata reconciliation

Submission-ready metadata without custom programming

Request SCE Demo

CTRenaissance® Clinical Data Analytics Platform

Integrated, validated, and automated — connecting 40+ data sources across eClinical systems and CROs into one unified, source-agnostic pipeline. From ingestion to reporting in a single cloud environment.
CTOS - Clinical trials Oversight
Real-time portfoliio visibility. Study-level and cross-study dashboards with automated KPI tracking and risk alerts.
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DMW- Data Management Workbench
Centralized data management across 22+ eClinical systems and 8+ CROs. Automated ingestion, cleaning, validation, and reconciliation.
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SCE  —  Statistical computing
Cloud-based programming in SAS, R, Python. Built-in audit trails, version control, and submission-ready TLF generation.
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CDR  —  Clinical data repository
Single source of truth. Source-agnostic data unification with automated CDISC standardization and real-time access across studies.
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RBQM  —  Risk-based quality management
Proactive risk detection aligned with ICH E6(R2). KRIs, QTLs, site-level scoring, and centralized monitoring dashboards.
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MDR  —  Metadata repository
Metadata lifecycle management. Reusable CRF libraries, automated CDISC mapping, versioning, and lineage tracking. No-code config.
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Organizations now must need a new operating model capable of scaling without proportional headcount growth.

Looking for Agentic AI for clinical trials?

Explore our Agentic AI Platform to see how AI agents are transforming study startup, data management, oversight, and regulatory submissions.

CTOS
DMW
SCE
CDR
RBQM
MDR

Clinical Trials Oversight System

Centralized data management across 22+ eClinical systems and 8+ CROs. Automated ingestion, cleaning, validation, and reconciliation.
What it does

Portfolio-leveland study-level dashboards with automated KPI tracking

Enrollment tracking, site performance monitoring, and milestone alerting

Risk assessment tools with threshold-based alerts across studies and sites

Role-based views for clinical ops, medical monitoring, and executives

Why it matters

Catch issues before they delay timelines

Shared views improve cross-functional alignment

Audit-ready oversight documentation

Request CTOS Demo

Data Management Workbench

Centralized data management across 22+ eClinical systems and 8+ CROs. Automated ingestion,cleaning, validation, and reconciliation.
What it does

Automated data ingestion, cleaning, standardization, and reconciliation

Configurable edit checks, validation rules, and automated query generation

SAE reconciliation and medical coding workflows

Low-code/no-code study setup and configuration

Why it matters

Significantly reduced manual effort on repetitive data tasks

Faster time to database lock through streamlined reconciliation

Scalable for complex multi-vendor, multi-CRO studies

Request DMW Demo

Statistical ComputingEnvironment

Cloud-based programming inSAS, R, Python. Built-in audit trails, version control, and submission-readyTLF generation.
What it does

Cloud-based platform with real-time data access — no IT delays

Support for SAS, R, Python, and other languages in collaborative workspaces

Built-inversion control, audit trails, and trace ability for regulatory submissions

Automated SDTM/ADaM standardization and TLF generation

Why it matters

Teams use the programming tools they already know

Full trace ability and audit trails for submission-ready outputs

Scale computing resourceson demand without infrastructure overhead

Request SCE Demo

Clinical Data Repository

Centralizeddata management across 22+ eClinical systems and 8+ CROs. Automated ingestion,cleaning, validation, and reconciliation.
What it does

Source-agnosticintegration from EDCs, CTMS, IVR/IWRS, safety databases, and more

AutomatedCDISC (SDTM/ADaM) standardization from day one

Real-timedata availability across studies and programs

Configurableaccess controls and role-based permissions

Why it matters

Eliminatesdelays from CRO data transfers — real-time access to outsourced data

Automatedstandardization reduces errors from manual processing

Full sponsor oversight without vendor dependency

Request CDR Demo

Risk-based Quality Management

Proactive risk detection aligned with ICH E6(R2). KRIs, QTLs, site-level scoring, andcentralized monitoring dashboards.
What it does

Key Risk Indicators (KRIs)with automated threshold-based alerting

QualityTolerance Limits (QTLs) configuration and tracking

Site-level and study-levelrisk scoring with integrated RACT

Centralizedrisk dashboards and actionable reports

Why it matters

Identifydata quality and operational risks before they escalate

Reducereliance on 100% on-site monitoring through centralized oversight

Real-timerisk alerts ensure timely intervention on safety signals

Request RQM Demo

Metadata Repository

Metadata lifecycle management. Reusable CRF libraries, automated CDISC mapping, versioning, and lineage tracking. No-code config.
What it does

Pre-built CRF library and reusable study design components

Automated CDISC mapping and metadata standardization

Metadata versioning, lineage tracking, and change management

No-code configuration with integration across EDC, CTMS, and eClinical systems

Why it matters

Reusable components accelerate study startup

Automated lineage tracking eliminates manual metadata reconciliation

Request MDR Demo

Software-enabled Clinical Data Services

Managed, supportive, and professional services powered by CTRenaissance®. Deep lifesciences expertise across the clinical data lifecycle.

Data services
RWE · EDC admin · Study design · Data mgmt · Medical coding · Standardization
Analytics & reporting
Role-based dashboards · Safety analytics · Custom reports
Biostatistics & programming
SAS, R, Python · SDTM/ADaM · TLF generation
Cloud & tech services
SOC 2 cloud hosting · Implementation · Managed support

Looking for Agentic AI for clinical trials?

Explore our Agentic AI Platform to see how AI agents are transforming study startup, data management, oversight, and regulatory submissions.

Explore Agentic AI platform
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GxP-aligned
21 CFR Part 11 ready
Human-in-the-loop governance

The New Operating Model

From Headcount Scaling to Supervised Execution

Traditional model

Humans execute work

Headcount scaling

Manual task resolution

Operational variability

AI Workforce Model

AI agents execute defined workflows

Human experts supervise and validate

Workflows operate across integrated systems

Outputs remain traceable and governed

What Is an AI Workforce

An AI Workforce for clinical trials is a system of supervised AI agents executing clinical workflows under human oversight within regulated environments.
Structured workflow execution
Human-in-the-loop supervision
Integration with clinical systems
Audit-ready traceability
Service-level accountability
What

What does Maxis AI do

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. Demonstrated cost efficiency in defined clinical workflows
Actions Logged
Traceable Logic
Transparent Decision Logic
Compliance Ready

How Maxis AI Works

Maxis AI agents execute end-to-end clinical trial workflows with human oversight.
Observe
Monitor clinical systems and ingest data from protocols, queries, safety reports, documents, and sites.
Reason
Identify patterns, flag risks, draft outputs, and trigger approved actions within defined governance guardrails.
Execute
Perform approved actions across Clinical Trial Operations, such as resolving queries, populating fields, etc.
Document
Every action is logged with full context. Human reviewers retain approval authority.

Maxis AI supports organizations and cross-functional teams responsible for delivering compliant, efficient, and scalable clinical trials.

Sponsors

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

CROs

Managing diverse client portfolios with consistent quality and delivery commitments

Site Networks

Seeking operational scale at compliance without adding headcount

Governance

Governance and Compliance Layer

Enterprise-grade governance designed for regulated environments. All agent activity aligns with:
GxP principles
21 CFR Part 11
ICH-GCP standards
SOC 2 Type II controls
Key safeguards
Role-based access controls
Encrypted data handling
Immutable audit logs
Inspection-ready traceability
IMPACT

Where AI Agents
Deliver Impact

Study Design & FeasibilitySite & Patient OperationsData ManagementSafety & PharmacovigilanceRisk & Quality ManagementRegulatory Submissions
Core Capabilities

Core Capabilities

AI Agents
Integration Layer
CES
No-Code Deployment

Verticalized AI Agents

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

Data management

Site monitoring

Safety and pharmacovigilance

Risk and quality management

Regulatory submissions

Integration Layer

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

Routes tasks across systems automatically

Integrates with EDC, CTMS, safety systems, imaging platforms, and eTMF

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.

Audit-ready decision trails

Measured task execution

Continuous supervised execution across workflows

Full visibility into agent activity

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

Verticalized AI Agents

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

Data management

Site monitoring

Risk and quality management

Integration Layer

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

Routes tasks across systems automatically

Integrates with EDC, CTMS, safety systems, imaging platforms, and eTMF

Continuous Supervised Execution

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

Audit-ready decision trails

Continuous detection of data quality risks

No-Code Deployment

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

Role-based permissions

Change-controlled deployment

Testimonials

Loved by Teams That
Scale Fast

Real stories from teams who streamlined their workflow and delivered more with less
SaaS Startup Webflow Template
Chloe Bennett
Product Manager
The structure is clear, the messaging flows naturally, and the design feels human—not corporate
SaaS Startup Webflow Template
Marcus Thompson
Founder & CEO
GoLive helped us launch faster with a site that finally feels as polished as our product.
SaaS Startup Webflow Template
Marcus Thompson
Content Lead, Loopline
Finally a SaaS template that balances clarity, personality, and performance
SaaS Startup Webflow Template
Ava Cooper
Customer Success Lead
We’re converting more demo requests simply because the site explains our value so well.
SaaS Startup Webflow Template
Chloe Bennett
Product Manager
The structure is clear, the messaging flows naturally, and the design feels human—not corporate
SaaS Startup Webflow Template
Marcus Thompson
Founder & CEO
GoLive helped us launch faster with a site that finally feels as polished as our product.
SaaS Startup Webflow Template
Marcus Thompson
Content Lead, Loopline
Finally a SaaS template that balances clarity, personality, and performance
SaaS Startup Webflow Template
Ava Cooper
Customer Success Lead
We’re converting more demo requests simply because the site explains our value so well.
BLOGS

Blogs

FAQ

All You Need to Know

Is Maxis AI’s agentic AI appropriate for 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.

How does Maxis AI apply agentic AI in clinical trials?

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.

Can Maxis AI integrate with existing clinical systems?

Yes. The AI Workforce integrates into existing electronic systems and workflows. It does not require core system replacement.

How is the AI Workforce different from analytics platforms?

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.

Does Maxis AI replace clinical teams?

No. The AI Workforce operates under defined supervision. It reduces repetitive workload while preserving clinical judgment and regulatory accountability.

What operational impact can organizations expect?

Organizations have demonstrated: Reduced repetitive manual effort, Improved workflow consistency, Increased execution throughput. Measured impact depends on workflow scope and deployment context.